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Full text of "DTIC ADA492477: Department of Clinical Investigation, Annual Research Progress Report, Fiscal Year 2006 (Madigan Army Medical Center)"

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Department 

of 

Clinical  Investigation 

Annual  Research  Progress 

Report 


Fiscal  Year  2006 

Madigan  Army  Medical  Center 
Tacoma,  Washington 


2 


REPORT  DOCUMENTATION  PAGE 


Form  Approved 
OMB  No.  0704-0188 


Public  reporting  burden  for  this  collection  of  information  is  estimated  to  average  1  hour  per  response,  including  the  time  for  reviewing  instructions,  searching  existing  data  sources,  gathering  and  maintaining  the 
data  needed,  and  completing  and  reviewing  this  collection  of  information.  Send  comments  regarding  this  burden  estimate  or  any  other  aspect  of  this  collection  of  information,  including  suggestions  for  reducing 
this  burden  to  Department  of  Defense,  Washington  Headquarters  Services,  Directorate  for  Information  Operations  and  Reports  (0704-0188),  1215  Jefferson  Davis  Highway,  Suite  1204,  Arlington,  VA  22202- 
4302.  Respondents  should  be  aware  that  notwithstanding  any  other  provision  of  law,  no  person  shall  be  subject  to  any  penalty  for  failing  to  comply  with  a  collection  of  information  if  it  does  not  display  a  currently 
valid  OMB  control  number.  PLEASE  DO  NOT  RETURN  YOUR  FORM  TO  THE  ABOVE  ADDRESS. 


1.  REPORT  DATE  (DD-MM-YYYY)  2.  REPORT  TYPE  3.  DATES  COVERED  (From  -  To) 

31-01-2007  Annual  (IAW  AR  40-38)  1  Oct  2005  -  30  Sep  2006 


4.  TITLE  AND  SUBTITLE  5a.  CONTRACT  NUMBER 

Madigan  Army  Medical  Center 


Annual  Research  Progress  Report 
Fiscal  Year  2006 


5b.  GRANT  NUMBER 


5c.  PROGRAM  ELEMENT  NUMBER 


6.  AUTHOR(S) 

Barbara  Jones,  Troy  Patience,  Lucy  Atoigue,  Athena  Rayner, 
Mary  Porreca,  Jill  Lund,  Lissette  Arroyo-Ortiz,  MAJ  Nancy 
Merrill,  Dr.  Lonnie  Lai,  CPT  Michael  Hartenstine,  COL  Paul 
Amoroso 


5d.  PROJECT  NUMBER 


5e.  TASK  NUMBER 


5f.  WORK  UNIT  NUMBER 


7.  PERFORMING  ORGANIZATION  NAME(S)  AND  ADDRESS(ES) 

Dept,  of  Clin.  Investigation 
Madigan  Army  Medical  Center 
Bldg.  9040,  Fitzsimmons  Dr. 

Attn:  MCHJ-CI 
Tacoma,  WA  98431-1100 


9.  SPONSORING  /  MONITORING  AGENCY  NAME(S)  AND  ADDRESS(ES) 

Clinical  Investigation 
Regulatory  Office 
Attn:  MCCS-GCI,  Bldg  2268 
1608  Stanley  Rd,  Suite  2 
Fort  Sam  Houston,  TX  78234 


12.  DISTRIBUTION  /  AVAILABILITY  STATEMENT 

Approved  for  public  release;  Distribution  unlimited 


8.  PERFORMING  ORGANIZATION  REPORT 
NUMBER 


10.  SPONSOR/MONITOR’S  ACRONYM(S) 

CIRO,  APR,  IRB,  IACUC 


11.  SPONSOR/MONITOR’S  REPORT 
NUMBER(S) 


13.  SUPPLEMENTARY  NOTES 

THE  FINDINGS  IN  THIS  REPORT  ARE  NOT  TO  BE  CONSTRUED  AS  AN  OFFICIAL  DEPARTMENT  OF  THE  ARMY 
POSITION  UNLESS  SO  DESIGNATED  BY  OTHER  AUTHORIZED  DOCUMENTS. 


14.  ABSTRACT 

This  report  covers  all  research  protocols  that  were  administratively  or  technically  supported 
by  the  Department  of  Clinical  Investigation,  Madigan  Army  Medical  Center,  Tacoma,  WA  during 
FY  2006.  Included  in  the  individual  data  summary  sheets  are  title,  investigators,  objective, 
technical  approach,  and  progress  for  FY  2006.  Also  included  in  the  report  are  personnel 
rosters  for  the  program,  funding  information,  presentations,  and  publications  emanating  from 
Madigan  Army  Medical  Center  during  FY  2006.  127  new  protocols  were  approved  and  103  were 
completed  in  FY  2006.  222  staff  members,  79  residents/fellows  and  18  non-Medical  Corps 
trainees  held  approved  research  protocols  in  FY  2006.  93  manuscripts  were  published  as  well 
as  53  abstracts  and  163  presentations. 


16.  SECURITY  CLASSIFICATION  OF: 


a.  REPORT 

U 


b.  ABSTRACT 

U 


c.  THIS  PAGE 

U 


17.  LIMITATION 

18.  NUMBER 

OF  ABSTRACT 

OF  PAGES 

UU 

552 

19a.  NAME  OF  RESPONSIBLE  PERSON 

Paul  J.  Amoroso,  COL,  MC 


19b.  TELEPHONE  NUMBER  (include  area 
code) 

(253)  968-1160,  DSN  782- 


Standard  Form  298  (Rev.  8-98) 

Prescribed  by  ANSI  Std.  Z39.18 


REPORTS  CONTROL  SYMBOL  RCS  MED-300(R1) 

ANNUAL  PROGRESS  REPORT 
30  SEPTEMBER  2006 

DEPARTMENT  OF  CLINICAL  INVESTIGATION 
MADIGAN  ARMY  MEDICAL  CENTER 
TACOMA,  WASHINGTON  98431 

THE  FINDINGS  IN  THIS  REPORT  ARE  NOT  TO  BE  CONSTRUED  AS  AN  OFFICIAL 
DEPARTMENT  OF  THE  ARMY  POSITION  UNLESS  SO  DESIGNATED  BY  OTHER 

AUTHORIZED  DOCUMENTS. 

DESTROY  THIS  REPORT  WHEN  NO  LONGER  NEEDED. 

DO  NOT  RETURN  IT  TO  THE  ORIGINATOR. 

APPROVED  FOR  PUBLIC  RELEASE 
DISTRIBUTION  UNLIMITED 


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Intentionally  left  blank 


6 


Table  of  Contents 


Introduction  &  Acknowledgments . 8 

Foreword . 9 

Objective,  Technical  Approach,  Staffing .  13 

Research  Funding .  14 

Progress  &  Program  Support .  15 

Committee  Members .  16 

Awards 

Graduation  Awards .  18 

Madigan  Research  Day  Awards .  19 

Presentations .  21 

Publications .  32 

Exempt  Protocols . 38 

Detailed  Summary  Sheets  -  Table  of  Contents .  39 

Department  of  Anesthesia  &  Operative  Services . 64 

Department  of  Clinical  Investigation .  67 

Hospital  Dental  Clinic .  80 

Department  of  Emergency  Medicine .  82 

Department  of  Family  Medicine .  89 

Graduate  Medical  Education . 106 

Health  Outcomes  Management  Division . 108 

Cardiology  Service,  Department  of  Medicine .  Ill 

Hematology/Oncology  Service,  Department  of  Medicine .  114 

Internal  Medicine  Service,  Department  of  Medicine .  200 

Nephrology  Service,  Department  of  Medicine .  216 

Neurology  Service,  Department  of  Medicine .  218 

Pulmonary  Disease  &  Critical  Care  Service,  Dept,  of  Medicine  ..  226 

Nutrition  Care  Division . 232 

Department  of  Nursing .  234 

Anesthesia  Students,  Department  of  Nursing .  250 

Department  of  Obstetrics/Gynecology .  252 

Department  of  Pathology .  280 

Department  of  Pediatrics .  285 

Department  of  Pharmacy . 343 

Department  of  Psychiatry .  352 

Department  of  Psychology .  356 

Department  of  Radiology .  362 

Special  Forces . 370 

General  Surgery  Service,  Department  of  Surgery . 373 

Ophthalmology  Service,  Department  of  Surgery .  429 

Orthopedics  Service,  Department  of  Surgery .  436 

Otolaryngology  Service,  Department  of  Surgery .  461 

Urology  Service,  Department  of  Surgery .  478 

Vascular  Surgery  Service,  Department  of  Surgery .  527 

Weed  Army  Community  Hospital .  546 

Index  with  Protocol  Numbers .  549 

Annual  Report  Distribution  List .  552 


7 


FISCAL  YEAR  2006 

DEPARTMENT  OF  CLINICAL  INVESTIGATION 
MADIGAN  ARMY  MEDICAL  CENTER 
TACOMA,  WASHINGTON  98431 

Introduction 

In  conducting  the  research  described  in  this  report,  the  investigators  adhered  to  the 
“Guide  for  the  Care  and  Use  of  Laboratory  Animals”  as  prepared  by  the  Committee  on  the 
Care  and  Use  of  Laboratory  Animals  of  the  Institute  of  Laboratory  Animal  Resources, 
National  Institutes  of  Health,  and  Title  9,  Subchapter  A,  Parts  I,  II,  and  III  of  the  Code  of 
Federal  Regulations.  The  investigators  adhered  to  Title  21,  Part  50  of  the  Code  of  Federal 
Regulations  and  the  recommendations  from  the  Declaration  of  Helsinki  in  the 
performance  of  investigations  involving  human  subjects. 

Acknowledgments 

The  DCI  staff  would  like  to  acknowledge  the  significant  and  varied  contributions  of 
many  individuals  and  organizations,  all  of  whom  were  instrumental  in  making  Madigan 
Army  Medical  Center  (MAMC)  research  a  resounding  success  in  2006.  We  appreciate  the 
support  and  participation  of  the  Western  Regional  Medical  Center  (WRMC)  Command 
Leadership  for  fostering  an  environment  where  "Care  with  Compassion"  is  the  motto  and 
meticulous  scientific  process  is  the  standard.  We  would  like  to  thank  our  many  corporate 
and  industry  research  sponsors  and  partners,  especially  those  foundations  that  foster 
military,  medical  research  and  support  the  Madigan  community.  We  also  would  like  to 
acknowledge  the  dedicated  members  of  the  Madigan  Institutional  Animal  Care  and  Use 
Committee  (IACUC),  the  Clinical  Investigation  Committee  (CIC),  and  the  Human  Use 
Committee  (HUC)  whose  tireless  efforts  ensured  quality  science  and  ethical  conduct  of  our 
research.  And,  last  but  certainly  not  least,  we  would  like  to  thank  the  hundreds  of 
MAMC’s  military  health  care  beneficiaries  who  volunteered  to  participate  in  so  many 
demanding  research  studies,  often  when  the  only  conceivable  benefits  were  to  individuals 
other  than  themselves. 


8 


Foreword 


Clinical  Studies  Service  (CSS) 

The  Clinical  Studies  Service  has  as  its  mission  to  increase  the  quantity  and  the 
quality  of  clinical  trials  that  are  open  and  available  to  military  beneficiaries.  This  is 
accomplished  by  working  with  investigators  in  the  clinics  to  determine  their  research 
interests,  commonly  seen  disease  states,  and  logistical  hurdles  to  implementing  trials. 
The  goal  is  that  each  clinic  have  the  support  staff  necessary  to  offer  patients  clinical  trial 
options  for  most  commonly  seen  diseases. 

Successful  collaborations  over  the  past  year  include  progress  toward  participation 
as  the  only  IRB  outside  of  the  National  Capitol  Area  to  join  the  United  States  Military 
Cancer  Institute  IRB.  Successes  in  terms  of  hiring  research  personnel  include 
participation  with  USUHS  to  provide  a  3-year  grant  to  hire  a  research  nurse  to  the 
Hematology/Oncology  Clinic  and  offering  a  contract  to  a  physician-researcher  to  perform 
clinical  trials  within  primary  care  clinics,  primarily  Internal  medicine  and  Family 
Practice.  Other  successes  include  recruiting  clinical  trials  to  multiple  specialty  services, 
including  Cardiology,  Oncology,  Orthopedic  Surgery,  and  Cardiothoracic  Surgery. 

The  goals  for  the  next  year  are  to  recruit  clinical  trials  to  MAMC  that  will  allow 
hiring  of  research  staff  in  the  Family  Medicine,  Neurology,  and  Emergency  Medicine 
services,  improve  the  collaboration  with  the  USMCI,  and  represent  MAMC  interests  with 
CIRO  in  simplifying  and  standardizing  research  protocols  and  IRB  practices,  with  a  goal 
of  increasing  collaboration  between  military  medical  centers. 


Laboratory  Animal  Resources  Service  (LARS) 

LARS  remains  heavily  involved  in  the  trauma  training  course  offered  to  combat  and 
combat  support  units  of  Ft.  Lewis  and  other  units  under  the  Western  Regional  Medical 
Command.  This  course  has  trained  over  220  medics,  physician  assistants,  nurses,  and 
doctors  in  combat  trauma  management;  64  Emergency  Department  residents  in 
emergency  procedures;  14  urology  residents  and  24  surgery  residents  in  advanced 
laparoscopic  techniques;  and  88  providers  in  pediatric  intubation.  LARS  has  supported 
the  training  of  more  than  72  Special  Forces  medics.  There  is  increased  collaboration 
between  LARS,  the  Anderson  Simulation  Center,  and  the  Medical  Simulation  Training 
Center  to  stay  current  with  simulator  technology  which  reduces  the  number  of  animals 
required  for  effective  training.  The  newt  limb  regeneration  study  is  ongoing.  LARS 
supports  research  studies  involving  cancer  metastasis,  hypoperfusion/reperfusion  injuries, 
and  acute  inflammatory  reactions.  There  are  new  protocols  being  planned  to  study 
effectiveness  of  a  new  hemorrhage  control  material. 


Research  Administration  Service  (RAS) 

FY06  was  a  typically  busy  year  for  RAS  with  a  total  of  127  new  protocols  and  460 
active  protocols.  New  initial  and  continuing  review  protocols  continued  to  show  100% 


9 


HIPAA  compliance.  New  protocols  reviewed  at  convened  IRB  meetings  averaged  less  than 
those  in  FY05  overall,  but  the  numbers  of  ERC  protocols  increased  slightly.  However, 
formal  research  conducted  in  MAMC  and  the  Western  Regional  Command  Medical 
continues  to  be  a  solid  and  viable  program.  No  RAS  personnel  staffing  changes  have 
occurred. 

The  internal  audit  program  continues  to  be  refined,  with  21  protocols  having  been 
audited.  Most  audits  have  shown  satisfactory  results;  however,  findings  in  one  instance 
raised  concern  about  the  conduct  of  retrospective  review  protocols  and  the  use  of  subject’s 
protected  health  information.  The  number  of  audits  planned  during  FY07  will  be  double 
those  conducted  in  FY06  and  will  include  a  few  minimal  risk  retrospective  review 
protocols  to  ascertain  whether  the  use  of  codes  and  the  de-linking  procedures  described  in 
the  protocol  are  being  adequately  carried  out. 

The  RAS/Protocol  Management  Quality  Improvement  Team  has  continued  to  refine 
and  implement  improvements  to  local  IRB  administrative  policies  and  procedures: 

1.  Updated  entire  SOP  book  in  preparation  for  FDA  inspection,  which  RAS  is  still 
awaiting. 

2.  Begun  consolidating  human  use  protocol  template  into  one  universal  format  for 
local  and  multicenter  studies. 

3.  Turned  the  Expedited  Review  Committee  (ERC)  into  a  weekly  (as  needed) 
meeting  for  reviewing  ERC  eligible  protocols. 

Participated  in  coordinating  2  semi-annual  Applied  Research  Training  (ART)  Courses 
(formerly  called  Introduction  to  Clinical  Research  Course),  which  are  held  in  collaboration 
with  the  MAMC  Faculty  Development  Fellows.  Attendance  averages  about  50  students. 
Additionally,  investigators  are  still  obtaining  the  required  Human  Subjects  Protections 
training  through  DCI’s  subscription  with  the  University  of  Miami’s  Collaborative  IRB 
Training  Initiative  (CITI). 

In  FY07,  RAS  plans  to: 

(1)  implement  a  universal  human  use  protocol  template; 

(2)  continually  expand  the  DCI  website  to  offer  more  information  and  reporting 
options  for  investigators; 

(3)  continue  to  develop  and  refine  the  constructive  internal  audit  program; 

(4)  participate  in  planning  the  semi-annual  ART  Course  and  annual  Madigan 
Research  Day; 

(5)  work  more  closely  with  the  Foundations  (Geneva,  Jackson,  and  True)  to  improve 
communication  for  the  research  program; 

(6)  host  and  conduct  the  annual  DCI  HELPER  Course  for  research  coordinators 
working  within  MAMC. 


Research  Operations  Service  (ROS) 

DCI’s  Research  Operations  Service  at  Madigan  Army  Medical  Center  experienced 
continuing  growth  in  FY  2006.  Acquisition  of  a  SELDI-TOF  mass  spectrophotometer 
ushered  in  the  official  start  of  high  throughput  proteomics  work  at  Madigan.  The  SELDI 


10 


technology  offers  enormous  potential  for  protein  biomarker  discovery  in  the  analysis  of 
clinical  samples  and  application  to  ongoing  research  projects.  ROS  made  significant 
progress  introducing  the  SELDI-based  high  throughput  proteomic  capabilities  to  MAMC. 
In  our  initial  longitudinal  studies  of  the  human  Pregnancy  Proteome,  study  staff  enrolled 
and  collected  samples  at  various  points  of  gestation  from  over  110  patients.  ROS  also 
welcomed  three  new  medical  technologists  to  the  lab  who  will  be  essential  in  supporting 
recent  increases  in  GME  research  activity  at  MAMC.  The  laboratory  maintained  active 
basic  research  protocols  with  4  of  6  medical  departments  at  MAMC  including  the 
departments  of  Surgery  (General  Surgery,  Urology,  and  Orthopedics),  Pediatrics, 
Pathology,  and  OB/GYN  (Maternal  Fetal  Medicine  Fellowship).  Residents  won  2  separate 
awards  at  the  9th  Annual  Madigan  Research  Day  for  research  conducted  within  the  lab.  In 
further  support  of  our  GME  mission,  ROS  hosted  the  2006  DCI  Molecular  Biology  Short 
Course.  The  5-day  lab  and  lecture  course  provides  novice  clinical  researchers  with 
perspective  on  modern  molecular  and  cellular  biology  techniques  and  the  relationship 
between  basic  and  clinical  research.  The  ROS  laboratory  made  marked  progress  on 
several  basic  science  research  protocols  including  but  not  limited  to  the  following:  a) 
methods  for  creating  transgenic  plants  to  produce  proteins  of  clinical,  environmental  and 
military-unique  utility;  b)  development  of  cell-based  assays  against  neurotoxins  and 
characterization  of  G  protein  coupled  receptors  using  neurons  derived  from  mouse 
embryonic  stem  cell  culture;  c)  characterization  of  the  CXCR4/SDF-lalpha  chemokine  axis 
as  a  potential  means  of  directing  therapeutic  cells  to  damaged  tissue;  d)  characterization 
of  the  molecular  mechanisms  of  limb  regeneration  in  newts.  ROS  maintained  an  active 
internship  program  with  Bates  Technical  College  wherein  interns  gain  valuable  real  world 
experience  while  increasing  laboratory  productivity.  In  FY07,  ROS  looks  forward  to 
promoting  sustainable  and  synergistic  research  efforts  among  laboratory  staff  and  medical 
center  residents  in  support  of  our  graduate  medical  education  mission. 


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12 


UNIT  SUMMARY  -  FISCAL  YEAR  2006 


A.  Objective: 

Provide  and  create  an  environment  to  support  clinical  and  basic  medical  research  within  Madigan 
Army  Medical  Center.  Clinical  Investigation  exists  to  further  the  highest  degree  of  medical 
readiness.  DCI  supports  the  Graduate  Medical  Education  mission  through  leadership  in  curriculum 
development,  medical  education  research,  and  military  unique  clinical  investigations,  as  well  as 
training  opportunities  available  through  institutional  programs  (ATLS,  PALS,  etc.). 

B.  Technical  Approach: 

All  research,  investigational  and  training  activities  within  the  Department  of  Clinical  Investigation 
are  conducted  under  the  guidance  of  the  Office  of  Human  Research  Protections  (OHRP),  Food  & 
Drug  Administration  (FDA),  AR  40-7,  AR  40-38,  AR  70-25,  and  AR  40-33.  Careful  monitoring  of  all 
approved  protocols  is  conducted  in  order  to  assure  strict  compliance  with  the  applicable  regulations. 

C.  Staffing: 


Name 

Rank 

MOS 

Title 

Amoroso,  Paul 

COL 

61N 

Chief,  DCI 

*Myers,  Jerome 

COL 

61U 

Chief,  DCI 

°McCune,  David 

LTC 

61B 

Clinical  Trials  Director 

Arroyo -Ortiz,  Lissette 

GSll 

0671 

Health  System  Specialist 

Patience,  Troy 

GSll 

1530 

Statistician  (Medicine) 

Atoigue,  Lucy 

GS06 

0318 

Secretary/Steno 

Porreca,  Mary 

GS05 

0303 

Research  Protocol  Clerk 

Merrill,  Nancy 

MAJ 

64C 

Chief,  Lab  Animal  Res  Svc 

*Gibson,  Steven 

GSll 

0301 

Trauma  Training  Specialist 

Karen  Van  Loon 

MSG 

91T 

Animal  Technologist  &  NCOIC 

*Phyall,  Shayla 

SPC 

91T 

Animal  Technologist 

Phillips,  Miemie 

SPC 

91T 

Animal  Technologist 

Spahn-Bridges,  Shelley 

WG05 

5048 

Animal  Caretaker 

*Theis,  Jennifer 

GSll 

0301 

Trauma  Training  Specialist 

*McNutt,  Patrick 

CPT 

71B 

Chief,  Research  Op  Svc 

“Celver,  Jeremy 

CPT 

71A 

Cell  Biologist 

Hartenstine,  Michael 

CPT 

71B 

Molecular  Biologist 

*Fannings,  Anthony 

SSG 

91K 

NCOIC 

Wright,  James 

GSll 

0644 

Medical  Technologist 

Bullock,  Jeff 

GSll 

0644 

Medical  Technologist 

DeHart,  Mary 

GSll 

0644 

Medical  Technologist 

*Murcin,  Lara 

GSll 

0644 

Medical  Technologist 

*Cederholm,  Heidi 

GSll 

0644 

Medical  Technologist 

*Bergmann,  Aspen 

GSll 

0644 

Medical  Technologist 

*Ippolito,  Danielle 

GSll 

0644 

Medical  Technologist 

Lai,  Lonnie 

GS13 

0601 

Chief,  Research  Administration  Svc 

Jones,  Barbara 

GSll 

0301 

Research  Protocol  Manager/Auditor 

Rayner,  Athena 

GS09 

0303 

Research  Protocol  Specialist 

Lund,  Jill 

GS07 

0303 

Research  Protocol  Assistant 

LEGEND  l*denotes  staffing  status  change! 
*Myers  -  PCS’d  in  Jul  2006 
*Phyall  -  PCS’d  in  Nov  2006 
*McNutt  -  PCS’d  in  Sep  2006 
*Murcin  -  Resigned  in  Oct  2005 
*Bergmann  -  New  Hire  in  Feb  2006 


*Gibson  —  Resigned  in  Jan  2006 

*Theis  -  New  Hire/Promotion  in  Oct  2005/Jul  2006 

*Fannings  -  PCS’d  in  Jun  2006 

*Cederholm  -  New  Hire  in  Feb  2006 

*Ippolito  -  New  Hire  in  May  2006 

°McCune  &  Celver  —  Assigned  part  time 


13 


Summary: 

Personnel: 

Authorized  Required 

Assigned 

Officers 

4  4 

4 

Civilians 

17  19 

17 

Enlisted 

4  4 

4 

D.  Funding: 

P8  Funds 

Civilian  Payroll 

$1,036,814 

Operations 

$149,550 

CEEP 

$286,941 

TDY  (CHE) 

$11,290 

TDY  (for  researchers  to  present) 

$41,734 

Reproduction  Requests 

$1,717 

Contracts 

$7,629 

MEDCASE 

$0 

Military  Payroll  (est.) 

P8  funds  total 

$558,232 

MAMC  Resource  Management  Division  Oversight 

Air  Force  (support  for  MFM)  $54,000 

Military  units  (support  for  Combat  Trauma  Training)  $71,932 

Internal  oversight  total 


Grants  Federal 

Henry  M.  Jackson  Foundation  $203,135 

The  Geneva  Foundation  (Tri-Service  Nursing)  $335,362 

T.R.U.E.  Foundation  $964 

Federal  grant  total 

Grants  Nonfederal 

Henry  M.  Jackson  Foundation  (CRADA)  $146,111 

The  Geneva  Foundation  (CRADA)  $334,876 

Non-federal  grant  total 


FY06  Research  Resources  Total 


$2,093,907 

$125,932 

$539,461 

$480,987 

$3,240,287 


14 


E.  Progress 

During  FY  2006,  there  were  464  active  protocols  that  received  administrative  and/or 
technical  support  during  the  year,  of  these,  317  are  presently  ongoing,  3  are  in  a 
suspended  status,  99  were  completed,  40  were  terminated,  4  are  IACUC  expired  protocols. 
The  principal  investigator  distribution  was  as  follows:  333  staff  protocols,  85  resident 
protocols,  18  fellow  protocols,  and  2  Special  Forces  animal  protocols.  There  were  127  new 
protocols,  of  which  10  were  Exempt,  59  were  ERC,  48  were  IRB,  and  10  were  IACUC 
protocols. 

There  were  93  publications  in  publicly  available  sources  and  163  presentations  at 
regional  or  national  meetings. 

F.  Program  Support 

Programs  supported  by  DCI:  10  internships,  15  residencies,  5  fellowships,  and  7  non- 
MC  programs;  they  are: 

Internships :  Emergency  Medicine,  Family  Practice,  General  Surgery,  Internal 
Medicine,  Neurology,  Obstetrics  and  Gynecology,  Orthopaedic  Surgery,  Pathology, 
Pediatrics,  and  Transitional  Year. 

Residencies :  Emergency  Medicine,  Family  Practice,  General  Surgery,  Internal 
Medicine,  Neurology,  Obstetrics  and  Gynecology,  Ophthalmology,  Oral  and  Maxillofacial 
Surgery,  Orthopaedic  Surgery,  Otolaryngology,  Pathology,  Pediatrics,  Preventive  Medicine 
(Public  Health),  Radiology  (Diagnostic),  and  Urology. 

Fellowships'.  Developmental  Pediatrics,  Faculty  Development  (Family  Practice), 
Geriatric  Medicine,  Maternal-Fetal  Medicine,  and  Urogynocology. 

Non-MC  programs'.  Diabetic  Foot  Fellowship,  Occupational  Therapy,  Pediatric 
Psychology,  Pharmacy  Practice,  Physician  Assistance  Program  (Emergency  Medicine  & 
Orthopaedics),  and  Podiatry. 

Other  training  protocols  supported  by  DCI: 

DCI:  203023,  203077,  203092,  206109 

Department  of  Surgery:  203016,  204058,  204101,  205017,  205079,  206030 
Department  of  Emergency  Medicine:  204028,  206078 
Special  Forces:  206018,  206106 


15 


G.  Committee  Members 


Clinical  Investigation  Committee 
COL  Paul  J.  Amoroso,  MC 
Chairman 


Chief  or  delegated  representative  of: 

Department  of  Emergency  Medicine 

Department  of  Family  Medicine 

Department  of  Medicine 

Department  of  Nursing 

Department  of  OB/GYN 

Department  of  Pathology 

Department  of  Pediatrics 

Department  of  Pharmacy 

Department  of  Preventive  Medicine 

Department  of  Radiology 

Department  of  Surgery 

Physical  Medicine  &  Rehabilitation  Service 

Department  of  Clinical  Investigation  (DCI) 

Clinical  Studies  Service,  DCI 

Medical  Statistician,  DCI 

Research  Administration  Service,  DCI 

Research  Operations  Service,  DCI 

General  Surgery  Research  Resident,  DCI 


16 


Human  Use  Committee 
COL  Paul  J.  Amoroso,  MC 
Chairman 


Chief  or  delegated  representative  of: 
Department  of  Nursing 
Department  of  Pathology 
Department  of  Pediatrics 
Department  of  Pharmacy 
Department  of  Radiology 
Department  of  Ministry  and  Pastoral  Care 
Research  Administration  Service,  DCI 
Social  Work  Service 
Center  Judge  Advocate 
Non-institutional  Member 


Institutional  Animal  Care  &  Use  Committee 
MAJ  Andrew  C.  Peterson,  MC 
Chairman 


Chief  or  delegated  representative  of: 

Department  of  Clinical  Investigation  (DCI) 

Department  of  Pathology 
Department  of  Medicine 
Department  of  Surgery 

Non-affiliated  Member  and  Alternate  Non-affiliated  Member 
Attending  Veterinarian,  DCI 
Animal  Care  Worker,  DCI 


17 


H.  Awards 


Each  of  the  following  awards  was  judged  based  on  a  submitted  manuscript. 

Major  General  Byron  L.  Steger  Research  Award 

This  award  is  given  to  a  resident,  submissions  are  judged  on  their  scientific  merit, 
relevance,  objectivity  of  evaluation,  interpretation  of  results,  and  the  potential  importance 
of  the  subject  of  the  research 

Recipient  of  this  award  for  2006:  CPT  James  Wang,  MC 

Manuscript:  Efficacy  of  Iron  in  Patients  with  Restless  Legs  Syndrome  and  a  Low-Normal 
Ferritin:  A  Randomized,  Double-Blind,  Placebo  Controlled  Study 

COL  Patrick  S.  Madigan  Foundation  Research  Award 

This  award  is  given  to  a  fellow,  submissions  are  judged  on  their  scientific  merit,  relevance, 
objectivity  of  evaluation,  interpretation  of  results,  and  the  potential  importance  of  the 
subject  of  the  research. 

Recipient  of  this  award  for  2006:  MAJ  Jennifer  L.  Gotkin,  MC 

Manuscript:  Progesterone  Reduces  Lipopoly saccharide  Induced  Interleukin- 6  Secretion  in 
Fetoplacental  Arteries,  Fractionated  Cord  Blood,  and  Maternal  Mononuclear  Cells 


Major  General  Kenyon  Joyce  Award 

This  award  is  given  to  staff,  submissions  are  judged  on  their  scientific  merit,  relevance, 
objectivity  of  evaluation,  interpretation  of  results,  and  the  potential  importance  of  the 
subject  of  the  research. 

Recipient  of  this  award  for  2006:  LTC  Bobby  C.  Howard,  MC,  USAF 

Manuscript:  A  Comparison  of  Oxytocin  Requirements  in  Patients  Randomized  to  Elective 
Induction  of  Labor  versus  Expectant  Management 


18 


Madigan  Research  Day  Awards 


These  awards  are  given  after  Madigan’s  Annual  Madigan  Research  Day  to  recognize  the 
best  presentation  in  the  each  of  the  following  six  sessions:  Military  Unique  Clinical 
Investigation,  Medical  Education  Research,  Experimental  Design,  Managed  Care/Health 
Outcomes,  Case  Report,  and  Poster.  This  year’s  winners  are: 

Military  Unique  Clinical  Investigation  -  CPT  Julie  Ake,  MC  for  presentation  entitled 
“Risk  Behavior,  Knowledge  and  Attitudes  of  ROTC  Cadets  Regarding  HIV/AIDS” 

Medical  Education  Research  (tie)  -  MAJ  Aaron  Saguil,  MC  for  presentation  entitled 
“The  Role  of  Evidence  and  Other  Determinants  in  Family  Medicine  Resident  Physician 
Discussions  of  Spirituality  with  Patients” 

Medical  Education  Research  (tie)  -  MAJ  Jean  Jones,  AN  for  presentation  entitled 
“Junior  Army  Nurse  Corps  (ANC)  Officers’  Experiences  &  Expectations  of  Head  Nurse 
(HN)  Leadership” 

Case  Report  -  CPT  Kerry  O’Brien,  MC  for  presentation  entitled  “Managing  Patients  with 
Rare  Antibodies  and  Multiple  Medical  Issues  is  a  Difficult  Problem  Requiring  a  Team 
Approach” 

Experimental  Design  -  CPT  Garth  Herbert,  MC  for  presentation  entitled 
“Intraperitoneal  LPS  Delivery  in  Mice  Causes  Multi-organ,  Coordinated  Modulation  of 
SDF-la  Production  over  a  72-Hour  Period” 

Managed  Care/Outcome  Studies  -  CPT  Jeffrey  Tebbs,  MS  for  presentation  entitled 
“Decreasing  Behavioral  Restraint  Use:  A  Workload  Management  Approach” 

Poster  -  1LT  Robin  Smith,  AN  for  presentation  entitled  “An  Evidence-Based  Clinical 
Intervention  Strategy  to  Reduce  Falls:  The  Next  Generation” 


Special  awards  presented  during  Madigan  Research  Day: 


BG  GEORGE  J.  BROWN  MENTOR’S  CUBE 

The  BG  George  J.  Brown  Mentor's  Cube  honors  the  vital  role  of  the  mentor  in  the 
process  of  medical  education  and  research.  Madigan  Research  Day  celebrates  the  breadth 
and  depth  of  scholarly  activity  performed  at  MAMC.  The  BG  George  J.  Brown  Mentor's 
Cube  honors  this  vital  core  attribute  of  excellence  in  medical  scholarship. 

Presented  to:  LTC  Peter  Napolitano,  MC 
Department:  Obstetrics/Gynecology 


19 


NANCY  J.  WHITTEN  OUTSTANDING  IRB  MEMBER  AWARD 


An  IRB  is  a  committee  designated  by  an  institution  to  review,  to  approve  the  initiation 
of,  and  to  conduct  periodic  review  of  biomedical  research  involving  human  subjects.  The 
primary  purpose  of  such  review  is  to  assure  the  protection  of  the  rights  and  welfare  of 
human  subjects.  An  outstanding  IRB  member  goes  the  extra  mile.  This  award  was 
created  to  honor  those  that  contribute  above  and  beyond  the  call  of  duty. 

Presented  to:  COL  Jerome  Myers,  MC 
Department:  Clinical  Investigation 


BG  MACK  C.  HILL  FACILITATOR’S  AWARD 

This  award  was  created  to  recognize  a  Madigan  member  who  has  helped  to  facilitate 
the  center's  research  mission  in  ways  that  are  not  always  apparent  to  the  general 
population.  This  individual  represents  the  epitome  of  selfless  service  through  their 
continual  and  frequent  transparent  support  of  others  success  ....  they  exhibit  a  generous 
customer  service  attitude. 

Presented  to:  CPT  Matthew  Miller,  JA 
Department:  Center  Judge  Advocate 


BG  MICHAEL  DUNN  ‘PRESS-ON’  AWARD 

The  award  is  an  obelisk  which  signifies  the  interconnecting  spheres  of  the  physical, 
mental  and  spiritual  in  the  human  experience.  The  BG  Michael  A.  Dunn  Award  recognizes 
that  the  attributes  of  persistence  and  determination  are  at  least  as,  and  perhaps,  more 
important  than  talent,  genius  or  education  in  reaching  meaningful  goals.  This  award, 
established  in  2005,  is  presented  annually  to  a  member  of  the  staff  whose  determination 
has  led  to  significant  contributions  in  Research,  Education,  Patient  Care  and/or 
Administrative  Procedures  over  the  past  twelve  months. 

Presented  to:  CPT  Jessica  Arens,  MS 
Department:  Psychiatry 


20 


I.  Presentations 


Department  of  Clinical  Investigation 

Merrill  NL.  US  Army  Veterinary  Corps.  Presented  at  WSU  Swine  Center,  Pullman,  WA,  March 
2006. 


Department  of  Emergency  Medicine 

Blankenship  RB.  Web  education:  an  introduction/overview.  Presented  at  American  College  of 
Emergency  Physicians  Advanced  Teaching  Fellowship,  Albuquerque,  NM,  September  2006. 

Blankenship  RB.  How  to  construct  an  online  lecture.  Presented  at  American  College  of  Emergency 
Physicians  Advanced  Teaching  Fellowship,  Albuquerque,  NM,  September  2006. 

Blankenship  RB.  Deploying  your  Web  training.  Presented  at  American  College  of  Emergency 
Physicians  Advanced  Teaching  Fellowship,  Albuquerque,  NM,  September  2006. 

Blankenship  RB.  Building  Interactive  Online  Content.  Presented  at  American  College  of 
Emergency  Physicians  Advanced  Teaching  Fellowship,  Albuquerque,  NM,  September  2006. 

Blankenship  RB.  The  Internet  as  an  Educational  Tool.  Presented  at  Joint  Services  Symposium 
2006,  San  Antonio,  TX,  March  2006. 

Blankenship  RB.  Thrombosis  of  a  Non-ruptured  Abdominal  Aortic  Aneurysm  in  a  48  year-old 
Female.  Presented  at  Joint  Services  Symposium  2006,  San  Antoino,  TX,  March  2006. 


Department  of  Family  Medicine 

Angwafo  NN.  Management  of  Cerebrospinal  Fluid  Rhinorrhea  in  Pregnancy.  Presented  at  9th 
Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Junnila  JF.  Do  Race  or  Rank  Predict  Receipt  of  Pap  Test  in  a  Military  Healthcare  System? 
Presented  at  USAFP  Annual  Scientific  Meeting,  Chicago,  IF,  March  2006. 

Pflipsen  MC.  Vitamin  B12  Deficiency  in  the  Type  2  Diabetic  Population.  Presented  at  9th  Annual 
Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Pflipsen  MC,  Oh  RC,  Saguil  A.  Vitamin  B12  Deficiency  in  the  Type  2  Diabetic  Population:  A 
Preliminary  Report.  Presented  at  USAFP  2006  Annual  Meeting  and  Exposition,  Chicago,  IF, 
March  2006. 

Runser  FA.  Esophagogastroduodenoscopy  by  a  Family  Physician:  A  Case  Series  Demonstrating 
Healthcare  Savings.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Runser  FA,  Short  MW.  Upper  Endoscopy  by  a  Family  Physician.  Presented  at  AAFP  National 
Scientific  Assembly,  Washington,  DC,  September  2006. 

Saguil  AA.  Residents  and  Patient  Spirituality.  Presented  at  American  Academy  of  Family 
Physicians  Scientific  Assembly,  Washington,  DC,  September  2006. 

Saguil  AA.  The  Role  of  Evidence  and  Other  Determinants  in  Family  Medicine  Resident  Physician 
Discussions  of  Spirituality  with  Patients.  Presented  at  9th  Annual  Madigan  Research  Day, 
Tacoma,  WA,  April  2006. 


21 


Medical  Education 


Stillsmoking  KL.  Simulation  Education:  The  Paradigm  in  Healthcare's  Training  Process. 
Presented  at  ASSN  of  Perioperative  Registered  Nurses,  Tacoma,  WA,  April  2006. 


Internal  Medicine  Service,  Department  of  Medicine 

Abbott  JT,  Davis  JL.  Post  operative  complication  after  tricuspid  /  pulmonmic  valve  replacement  in 
a  patient  with  metastatic  carcinoid  syndrome.  Presented  at  Army  American  College  of  Physicians 
Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Ake  JA.  Risk  Behavior,  Knowledge  and  Attitudes  of  ROTC  Cadets  Regarding  HIV/AIDS. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Ake  JA,  Coyle  JR,  Wojciehowski  AO,  Morris  JT.  Risk  behavior,  knowledge  and  attitudes  of  ROTC 
cadets  regarding  HIV/AIDS.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting, 
San  Antonio,  Tx,  November  2005. 

Ake  JA,  Erickson  JC,  Lowry  KJ.  Cerebral  aneurysmal  arteriopathy  associated  with  adulthood 
HIV  infection.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio, 
TX,  November  2005. 

Ake  JA,  Mysliwiec  AG,  Mysliwiec  V.  Intrathoracic  granulocytic  sarcoma  presenting  with  pleural 
effusion  in  a  patient  with  CMML.  Presented  at  Army  American  College  of  Physicians  Annual 
Meeting,  San  Antonio,  TX,  November  2005. 

Bauler  KC,  Harner  KC,  Niven  AS.  A  patient  with  progressive  dyspnea  and  skin  thickening:  A 
treatment  dilemma.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San 
Antonio,  TX,  November  2005. 

Broy  CC.  Gitelman's  Disease  in  a  Patient  with  Nephrocalcinosis  Secondary  to 
Hyperparathyroidism.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Broy  CC,  Bennett  SP.  Partial  Anomalous  Pulmonary  Venous  Return.  Presented  at  Army 
American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Coyle  JR,  Harner  KC.  Dactylitis  Secondary  to  Systemic  Lupus  Erythematosus.  Presented  at  Army 
American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

DeHaan  PJ,  Mysliwiec  V.  An  Unusual  Case  of  an  Exudative  Lymphocyte- Predominant  Pleural 
Effusion.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX, 
November  2005. 

DeHaan  PJ,  Rinard  JP,  Roth  BJ.  Dose  adherence  to  the  American  Thoracic  Society  (ATS) 
treatment  guidelines  for  parapneumonic  effusions  affect  outcome?  Presented  at  Army  American 
College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

DeHaan  PJ,  Rinard  JP,  Roth  BJ.  Dose  Adherence  to  the  American  Thoracic  Society  (ATS) 
Treatment  Guidelines  for  Parapneumonic  Effusions  Affect  Outcome?  Presented  at  American 
College  of  Physicians  Annual  Meeting,  Philadelphia,  PA,  April  2006. 

Feaver  AA,  Derrick  BC,  Peterson  CK.  Results  from  the  diabetes  care  center:  A  disease  targeting 
approach.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX, 
November  2005. 

Feaver  AA,  Derrick  BC,  Peterson  CK.  Results  from  the  diabetes  care  center:  A  disease  targeting 
approach.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  Seattle,  WA, 
November  2005. 


22 


Feaver  AA,  Derrick  BC,  Peterson  CK.  Results  from  the  Diabetes  Care  Center:  A  Disease  Targeted 
Approach.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Fischer  CJ,  Gibson  CA.  Chronic  urticaria:  Resolution  with  total  thyroidectomy.  Presented  at 
Washington  State  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November 
2005. 

Fischer  CJ,  Peterson  CK,  Watts  JA.  Subspecialty  elective  participation  by  internal  medicine 
housestaff  and  ABIM  certification  examination  performance.  Presented  at  SGIM  Annual  Meeting, 
Los  Angeles,  CA,  April  2006. 

Kiley  CA.  Use  of  CT  Scan  Pulmonary  Angiography  (CTPA)  in  the  Evaluation  of  Venous 
Thromboembolism  (VTE):  An  Examination  of  Hospital  Referral  Practices.  Presented  at  9th  Annual 
Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Kiley  CA,  Lowry  KJ,  Mysliwiec  V.  Use  of  CT  Scan  Pulmonary  Angiography  (CTPA)  in  the 
Evaluation  of  Venous  Thromboembolism  (VTE):  An  Examination  of  Hospital  Referral  Practices. 
Presented  at  American  College  of  Physicians  Annual  Meeting,  Philadelphia,  PA,  April  2006. 

Kiley  CA,  Mysliwiec  V,  Lowry  KJ.  Use  of  CTPA  in  evaluation  of  venous  thromboembolism  -  an 
examination  of  hospital  referral  practices.  Presented  at  Army  American  College  of  Physicians 
Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Kwon  HP,  Lowry  KJ.  Atypical  sepsis  in  an  intravenous  drug  user.  Presented  at  Army  American 
College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Kwon  HP,  Mysliwiec  V.  A  Rare  Case  of  Hemoptysis.  Presented  at  Army  American  College  of 
Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Owshalimpur  D,  Cushner  HM,  Lee  JY,  Starnes  BW.  Does  high  resistive  index  by  Doppler 
ultrasound  predict  small  kidney.  Presented  at  Army  American  College  of  Physicians  Annual 
Meeting,  San  Antonio,  TX,  November  2005. 

Owshalimpur  D,  Kunz  J,  Kenwood  B.  Percutaneous  treatment  of  a  kinked  LIMA.  Presented  at 
Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Reilly  SC,  Lowry  KJ.  Failed  Medical  Management  of  a  MRSA  Sternoclavicular  Septic  Arthritis. 
Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November 
2005. 

Sapp  JE,  Ake  JA,  Morris  JT,  Niven  AS,  Mysliwiec  AG.  Metastatic  Melanoma  in  an  HIV-Positive 
53  year-old- male.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San 
Antonio,  TX,  November  2005. 

Wang  JY.  Efficacy  of  Iron  in  Patients  with  Restless  Legs  Syndrome  and  a  Low-Normal  Ferritin:  A 
Randomized,  Double-Blind,  Placebo  Controlled  Study.  Presented  at  9th  Annual  Madigan  Research 
Day,  Tacoma,  WA,  April  2006. 

Wang  JY.  Efficacy  of  iron  in  patients  with  restless  leg  syndrome  and  a  low-normal  ferritin:  a 
randomized,  double-blind,  placebo  controlled  study.  Presented  at  SLEEP  2006  20th  Anniversary 
Meeting  of  the  Associated  Professional  Sleep  Society,  Salt  Lake  City,  UT,  June  2006. 

Wang  JY,  Fischer  CJ,  DeHaan  PJ,  Owshalimpur  D,  Mysliwiec  AG.  Efficacy  of  iron  in  patients 
with  restless  legs  syndrome  and  low-normal  ferritin:  a  randomized,  double-blind,  placebo 
controlled  study.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San 
Antonio,  TX,  November  2005. 

Wang  JY,  McKinley  BT,  Lee  JY.  Atypical  presentation  of  Sjogren's  syndrome  manifesting  as  acute 
renal  failure.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio, 

TX,  November  2005. 


23 


Wilton  NK,  Howden  JK.  Acute  pancreatitis  in  a  patient  secondary  to  volvulus  after  simultaneous 
pancreas  and  kidney  transplant.  Presented  at  Army  American  College  of  Physicians  Annual 
Meeting,  San  Antonio,  TX,  November  2005. 

Witters  RA,  Lowry  KJ.  Linezolid  and  atypical  mycobacteria.  Presented  at  Army  American  College 
of  Physicians  Annual  Meeting,  San  Antonio,  TX,  November  2005. 

Witters  RA,  Morris  JT,  Mahlen  SD.  A  rare  case  of  sepsis  caused  by  Erysipelothrix  Rhusiopathiae 
bacteremia.  Presented  at  Army  American  College  of  Physicians  Annual  Meeting,  San  Antonio,  TX, 
November  2005. 

Wojciehowski  AO,  Rutberg  S.  Broken  Hearts:  A  Case  Series  of  Catecholamine  Induced 
Cardiomyopathy  and  Literature  Review.  Presented  at  Army  American  College  of  Physicians 
Annual  Meeting,  San  Antonio,  TX,  November  2005. 


Neurology  Service,  Department  of  Medicine 

Flynn  FG.  Update  on  Normal  Pressure  Hydrocephalus.  Presented  at  25th  Annual  AMEDD 
Neurology  Conference,  San  Antonio,  TX,  November  2005. 

Hohler  AD.  Domestic  Violence  Education  and  Practice  Improvement.  Presented  at  American 
Academy  of  Neurology,  San  Diego,  CA,  April  2006. 

Hohler  LD.  Parkinsonism  Related  to  Oral  Ingestion  of  Manganese.  Presented  at  American 
Academy  of  Neurology,  April  2006. 

Lee  JD.  Neurological  Perspectives  in  End  of  Life  Care.  Presented  at  Washington  State  Medical 
Association  Annual  Meeting,  Seattle,  WA,  September  2006. 

Lee  JD.  Neurological  Complications  of  Thermal  Injury.  Presented  at  American  Academy  of 
Neurology,  San  Diego,  CA,  April  2006. 

Scott  BR.  Horner  Syndrome.  Presented  at  Pacific  Northwest  Neuro-Ophthalmology  Society 
Meeting,  Casey  Eye  Institute,  Portland,  OR,  November  2005. 

Theeler  BJ.  Prevalence  and  Impact  of  Migraine  among  U.S.  Army  Soldiers  Deployed  to  a  Combat 
Theater.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Theeler  BJ,  Mercer  R,  Erickson  JC.  Prevalence  and  Impact  of  Migraine  Among  U.S.  Soldiers 
Deployed  to  a  Combat  Theater.  Presented  at  American  Headache  Society  Annual  Meeting,  Los 
Angeles,  CA,  June  2006. 


Department  of  Nursing 

Bryant  JV.  The  Effects  of  St.  John's  Wort  on  Emergence  Time  from  General  Anesthesia  in  Male 
Sprague-Dawley  Rats  (Rattus  norvegicus)  Undergoing  Abdominal  Surgery.  Presented  at  9th 
Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Carney  LM.  Call  to  duty:  NP's  on  the  Front  Lines.  Presented  at  AANP,  June  2006. 

Garner  BK.  ICU  Restraint  Protocol  Initiative  and  Compliance  in  the  Intensive  Care  Units. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Hopkins  DL.  Stress,  Role  Strain,  Health  &  Attrition  in  Junior  Enlisted  Air  Force  Women  with  and 
without  Preschool  Children.  Presented  at  38th  Biennial  Sigma  Theta  Tau  International 
Convention,  Indianapolis,  ID,  November  2005. 

Jones  JM.  Junior  Army  Nurse  Corps  (ANC)  Officers'  Experiences  &  Expectations  of  Head  Nurse 
(HN)  Leadership.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


24 


Jones  JM,  Loan  LA,  Cofield  TS,  Blackman  LL.  Junior  ANC  Officers'  Experiences  &  Expectations 
of  Head  Nurse  Leadership.  Presented  at  Phyllis  J.  Verhonick  Nursing  Research  Conference,  San 
Antonio,  TX,  May  2006. 

Kamara  J.  The  Impact  of  Inpatient  Physician  Order  Entry  on  Medication  Administration  Error 
Rates  in  the  Neonatal  Intermediate  and  Intensive  Care  Units.  Presented  at  9th  Annual  Madigan 
Research  Day,  Tacoma,  WA,  April  2006. 

Raymond  SM.  From  Numbers  to  Knowledge  to  Know-How:  Using  Pressure  Ulcer  Prevalence  Data 
to  Improve  Patient  and  Cost  Outcomes.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma, 
WA,  April  2006. 

Reyes  SD,  Looper  R.  Academic  Readiness  and  Board  of  Nursing  Examiners  Brief.  Presented  at 
AMEDD  C  &  S  Fort  Sam  Practical  Nurse  Educators  Conference,  San  Antonio,  TX,  August  2006. 

Ribbing  SK.  Effects  of  Chrysin  on  Emergence  Time  in  Sprague-Dawley  Rats  after  Laparotomy. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Serna  ED.  A  Continuous  Quality  Improvement  Project  to  Examine  and  Enhance  Nurse's 
Management  of  Tube  Feedings.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA, 
April  2006. 

Smith  RD.  An  Evidence-Based  Clinical  Intervention  Strategy  to  Reduce  Falls:  The  Next 
Generation.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Tebbs  JS.  Decreasing  Behavioral  Restraint  Use:  A  Workload  Management  Approach.  Presented  at 
9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


Anesthesia  Students,  Department  of  Nursing 

Andalis  MA,  Ribbing  SK,  Weston  EM.  The  Effects  of  Chrysin,  a  Passiflora  Incarnata  Extract,  on 
Emergence  Time  from  Anesthesia  in  Male  Sprague-Dawley  Rats  after  Intra-abdominal  Surgery. 
Presented  at  Annual  Meeting,  American  Association  of  Nurse  Anesthetists,  Cleveland,  OH,  August 
2006. 

Bryant  JV,  Frondozo  RR,  King  TL,  Robinson  JS.  The  Effects  of  St.  John's  Wort  on  Emergence 
Time  from  General  Anesthesia  in  Sprague-Dawley  Rats  (Rattus  norvegicus)  Undergoing 
Abdominal  Surgery.  Presented  at  Annual  Meeting,  American  Association  of  Nurse  Anesthetists, 
Cleveland,  OH,  August  2006. 

Downs  AM.  Efficacy  of  Preoperative  Valerian  on  Day  of  Surgery  Anxiety.  Presented  at  Phyllis  J. 
Verhonick  Nursing  Research  Course,  San  Antonio,  TX,  May  2006. 

Harm  PS.  Infection  with  Epidural  Placement  the  Role  of  Asepsis  in  Reducing  the  Incidence  of 
Infections  Complications.  Presented  at  Washington  Association  of  Nurse  Anesthetists,  Seattle, 

WA,  April  2006. 

Kondrat  PM.  Current  Perioperative  Issues:  Battlefield  Lessons  Learned.  Presented  at  8th  Annual 
TriService  Perioperative  Nursing  Symposium,  Washington,  DC,  March  2006. 

Whitacre  WC.  Anesthesia  in  an  Austere  Environment:  Afghanistan.  Presented  at  Washington 
Association  of  Nurse  Anesthetists,  Seattle,  WA,  April  2006. 

Wulf  PM,  Long  AL,  Arredondo  A,  Petty  LA,  Marshall  WB,  Reilly  M.  The  Laryngeal  Mask  Airway: 
Comparison  of  Two  Insertion  Techniques  and  Waste  Anesthetic  Gas  Leakage.  Presented  at 
American  Association  of  Nurse  Anesthetists,  November  2005. 

Zwerling  A,  Fish  D.  Approaching  the  Patient  with  the  Difficult  Airway.  Presented  at  Washington 
Association  of  Nurse  Anesthetists,  Seattle,  WA,  April  2006. 


25 


Nursing  Research  Service,  Department  of  Nursing 

Argueta  SJ.  Nursing  Workload  Data  Collection  in  the  Post  Anesthesia  Care  Unit.  Presented  at 
Phyllis  J.  Verhonick  Nursing  Research  Conference,  San  Antonio,  TX,  May  2006. 

Hemman  EA.  Evaluation  of  the  Semi-Annual  Combat  Medic  Skills-Validation  Test  (SACMS-VT). 
Presented  at  Tri-Service  Nursing  Research  Conference:  13th  Biennial  Phyllis  J.  Verhonick 
Nursing  Research  Course,  San  Antonio,  TX,  April  2006. 

Hemman  EA.  Evaluation  of  the  Semi-Annual  Combat  Medic  Skills-Validation  Test.  Presented  at 
Tacoma  General  (Multicare),  Tacoma,  WA,  June  2006. 

Hopkins  DL.  Stress,  Role  Strain,  Health  &  Military  Career  Aspiration  in  Junior  Enlisted  AirForce 
Women  With  &  Without  Preschool  Children.  Presented  at  14th  Biennial  Phyllis  J.  Verhonick 
Nursing  Research  Course,  San  Antonio,  TX,  May  2006. 

Ketz  AK.  The  Experience  and  Management  of  Phantom  Limb  Pain  in  Patients  with  Traumatic 
Amputation  Resulting  from  Combat  or  Training  Injury.  Presented  at  Phyllis  J.  Verhonick  Nursing 
Research  Conference,  San  Antonio,  TX,  May  2006. 

Loan  LA,  Whitney  D,  Taylor  JA.  The  Impact  of  Inpatient  Physician  Order  Entry  on  Medication 
Administration  Errors  Rates  in  the  Neonatal  Intermediate  &  Intensive  Care  Units.  Presented  at 
Phyllis  J.  Verhonick  Nursing  Research  Conference,  San  Antonio,  TX,  May  2006. 

McCarthy  MS,  Simonson  K,  Sorensen  D,  Bamgartner  B,  Demars  S.  Perioperative 
Immunonutrition  for  Head  and  Neck  Cancer:  A  Feasibility  Study.  Presented  at  14th  Biennial 
Phyllis  J.  Verhonick  Nursing  Research  Course,  San  Antonio,  TX,  May  2006. 

Schlicher  ML.  It's  a  Small  World  After  All...  Using  Nanotechnology  in  Nursing  &  Medicine. 
Presented  at  2006  National  Conference  of  the  American  Association  of  Critical  Care  Nurses, 
Anaheim,  CA,  May  2006. 

Smith  RD.  An  Evidence-Based  Clinical  Intervention  Strategy  to  Reduce  Falls:  The  Next 
Generation.  Presented  at  14th  Biennial  Phyllis  J.  Verhonick  Nursing  Research  Course,  San 
Antonio,  TX,  May  2006. 

Trego  LL.  Military  Women's  Thoughts  on  Menstruation  and  Menstrual  Suppression  During 
Deployment.  Presented  at  Pacific  Nursing  Research  Conference,  Honolulu,  HI,  February  2006. 

Trego  LL.  Military  Women's  Thoughts  on  Menstruation  and  Menstrual  Suppression  During 
Deployment.  Presented  at  The  Association  of  Women's  Health,  Obstetric,  and  Neonatal  Nurses 
(AWHONN),  Baltimore,  MD,  June  2006. 


Department  of  Obstetrics/Gynecology 

Buchard  E  ,  Deering  SH,  Kuskowski  LJ,  Miller  C,  Driggers  R.  Incidental  finding  of  angular 
pregnancy  delivered  at  35  weeks  for  oligohydramnios:  A  case  report  and  literature  review. 
Presented  at  44th  Annual  Armed  Forces  District  Meeting  of  the  American  College  of  Obstetricians 
&  Gynecologists,  Seattle,  WA,  November  2005. 

Burris  AC.  Resident  Training  in  Assessment  of  the  Sexual  Assault  Patient  Utilizing  Simulation. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Burris  AC,  Deering  SH,  Chinn  M.  Resident  Training  in  Assessment  of  the  Sexual  Assault  Patient 
Utilizing  Simulation.  Presented  at  Council  on  Resident  Eduation  in  OB/GYN  (CREOG)  and  The 
Association  of  Professors  of  Gynecology  and  Obstetrics  (APGO)  Annual  Meeting,  Orlando,  FL, 
March  2006. 

Burris  AC,  Shields  AD,  Deering  SH.  Ovarian  Vein  Thrombosis  in  Early  Pregnancy.  Presented  at 
Annual  ACOG  Armed  Forces  District  Meeting,  Seattle,  WA,  November  2005. 


26 


Deering  SH.  Simulation  Training  for  Postpartum  Hemorrhage.  Presented  at  Council  on  Residdent 
Education  in  Obstetrics  and  Gynecology  (CREOG)  and  The  Association  of  Professors  of 
Gynecology  and  Obstetrics  (APGO)  Annual  Meeting,  Orlando,  FL,  March  2006. 

Deering  SH.  Interactive  Simulation  Technologies  in  OB/GYN:  Simulation  Symposium.  Presented 
at  44th  Annual  Armed  Forces  District  Meeting  of  the  American  College  of  Obstetricians  & 
Gynecologists,  Seattle,  WA,  November  2005. 

Gotkin  JL.  Progesterone  Reduces  Lipopolysaccharide  Induced  Interleukin- 6  Secretion  in 
Fetoplacental  Arteries,  Fractionated  Cord  Blood,  and  Maternal  Mononuclear  Cells.  Presented  at 
9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Gotkin  JL,  Flood  SK  ,  Deering  SH.  A  new  case  of  an  old  problem:  A  case  report  of  sepsis  resulting 
from  attempted  self-termination.  Presented  at  44th  Annual  Armed  Forces  District  Meeting  of  the 
American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November  2005. 

Gotkin  JL,  McNutt  PM,  Celver  JP,  Shields  AD,  Wright  JR,  Hoeldtke  NJ,  Napolitano  PG. 
Progesterone  Reduces  Lipopolysaccharide  Induced  Inflammatory  Cytokine  Secretion  in 
Fetoplacental  Arteries  and  Fractionated  Cord  Blood.  Presented  at  44th  Annual  Armed  Forces 
District  Meeting  of  the  American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November 
2005. 

Gotkin  JL,  McNutt  PM,  Celver  JP,  Shields  AD,  Wright  JR,  Hoeldtke  NJ,  Napolitano  PG. 
Progesterone  Reduces  Lipopolysaccharide  Induced  Inflammatory  Cytokine  Secretion  in 
Fetoplacental  Arteries  and  Fractionated  Cord  Blood.  Presented  at  44th  Annual  Armed  Forces 
District  Meeting  of  the  American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November 
2005. 

Gotkin  JL,  McNutt  PM,  Celver  JP,  Shields  AD,  Wright  JR  ,  Hoeldtke  NJ,  Napolitano  PG. 
Progesterone  Reduces  Lipopolysaccharide  Induced  Inflammatory  Cytokine  Secretion  in 
Fetoplacental  Arteries  and  Fractionated  Cord  Blood.  Presented  at  26th  Annual  Meeting  of  the 
Society  for  Maternal-Fetal  Medicine,  Miami,  FL,  February  2006. 

Gotkin  JL,  Shields  A,  Napolitano  P,  McNutt  P,  Celver  J,  Wright  J.  Progesterone  Reduces 
Lipopolysaccharide  Induced  Inflammatory  Cytokine  Secretion  in  Fetoplacental  Arteries  & 
Fractionated  Cord  Blood.  Presented  at  Society  for  Maternal  Fetal  Medicine  Annual  Meeting, 
Miami,  FL,  February  2006. 

Guidry  BA,  Napolitano  PG.  Screening  for  Depression  at  Postpartum  Appointments.  Presented  at 
44th  Annual  Armed  Forces  District  Meeting  of  the  American  College  of  Obstetricians  & 
Gynecologists,  Seattle,  WA,  November  2005. 

Han  JJ,  Shen-Gunther  J.  Accuracy  of  Office  Endometrial  Biopsy:  Comparison  of  Biopsy  and 
Hysterectomy  Findings.  Presented  at  Annual  ACOG  Armed  Forces  District  Meeting,  Seattle,  WA, 
October  2005. 

Paonessa  DJ.  17-Hydroxyprogesterone  Caproate  Reverses  Thromboxane  Induced  Vaso¬ 
constriction  of  Fetal- Placental  Arteries  in  the  Ex  Vivo  Placental  Cotyledon  Model.  Presented  at  9th 
Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Paonessa  DJ,  Napolitano  PG,  Shields  AD,  Celver  JP,  Howard  BC,  Gotkin  JL,  Deering  SH, 

Hoeldtke  NJ.  The  Effect  of  Cholic  Acid  on  Placental  Artery  Perfusion  Pressure  in  the  Ex-Vivo 
Placental  Cotyledon  Model.  Presented  at  44th  Annual  Armed  Forces  District  Meeting  of  the 
American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November  2005. 

Paonessa  DJ,  Shields  AD,  Celver  JP,  Howard  BC,  Gotkin  JL,  Hoeldtke  NJ,  Napolitano  PG.  17-P 
Hydroxyprogesterone  Caproate  Reverses  Thromboxane  Induced  Vasoconstriction  of  Fetoplacental 
Arteries  in  the  Ex-Vivo  Placental  Cotyledon  Model.  Presented  at  44th  Annual  Armed  Forces 


27 


District  Meeting  of  the  American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November 
2005. 


Saunders  RD,  Thomson  SB,  Shields  AD.  Renal  Tubular  Acidosis  Presenting  as  Hypokalemia  in 
Pregnancy:  A  Case  Report  and  Review  of  Literature.  Presented  at  Annual  ACOG  Armed  Forces 
District  Meeting,  Seattle,  WA,  October  2005. 

Sessions  DC,  Napolitano  PG.  Birth  weight  and  macrosomia:  Army  versus  Navy  in  the  Puget 
Sound.  Presented  at  Annual  ACOG  Armed  Forces  District  Meeting,  Seattle,  WA,  October  2005. 

Shen-Gunther  J.  Hereditary  Cancer  Genetic  Testing:  Referral  Patterns  and  Outcomes.  Presented 
at  Annual  ACOG  Armed  Forces  Distric  Meeting,  Seattle,  WA,  October  2005. 

Shen-Gunther  J.  Extreme  Drug  Resistance  Assay  of  Transitional  Cell  Ovarian  Carcinoma. 
Presented  at  Annual  ACOG  Armed  Forces  District  Meeting,  Seattle,  WA,  October  2005. 

Shen-Gunther  J.  Does  Early  Treatment  with  Pegylated  Liposomal  Doxorubicin  Improve  Survival 
Compared  to  Topotecan  in  Patients  with  Recurrent  Ovarian  Cancer?  Presented  at  Society  of 
Gynecologic  Oncologists  2006  Annual  Meeting,  Palmsprings,  CA,  March  2006. 

Shields  AD,  Hill  Dl.  Management  of  Aplastic  Anemia  Diagnosed  in  Pregnancy:  A  Case  Report  and 
Review  of  the  Literature.  Presented  at  44th  Annual  Armed  Forces  District  Meeting  of  the 
American  College  of  Obstetricians  &  Gynecologists,  Seattle,  WA,  November  2005. 

Temple  ST,  Shields  AD.  Fatal  Congenital  Cardiomyopathy  in  Type  I  Myotonic  Dystrophy. 
Presented  at  44th  Annual  Armed  Forces  District  Meeting  of  the  American  College  of  Obstetricians 
&  Gynecologists,  Seattle,  WA,  November  2005. 

Wakefield  CL.  GIST  (Gastrointestinal  Stromal  Tumor)  of  the  Vagina.  Presented  at  Annual  ACOG 
Armed  Forces  District  Meeting,  Seattle,  WA,  October  2005. 

Wilson  KL,  Lattu  AL,  Lucas  W.  Incisional  Endometrioma  Following  Cesarean  Delivery.  Presented 
at  Annual  ACOG  Armed  Forces  District  Meeting,  Seattle,  WA,  October  2005. 

You  W,  Driggers  R,  Bobo  W,  Deering  SH.  Treatment  of  anorexia  nervosa  in  pregnancy:  A  case 
report  and  review  of  the  literature.  Awarded  Outstanding  Poster.  Presented  at  44th  Annual 
Armed  Forces  District  Meeting  of  the  American  College  of  Obstetricians  &  Gynecologists,  Seattle, 
WA,  November  2005. 

Zalucki  CM.  Paroxysmal  Nocturnal  Hemoglobinuria  in  Pregnancy.  Presented  at  Annual  ACOG 
Armed  Forces  District  Meeting,  Seattle,  WA,  October  2005. 


Department  of  Pathology 

O'Brien  KL.  Three  Unusual  Histologic  Variants  of  Fibrous  Papule.  Presented  at  International 
Society  of  Dermatopathology  9th  Joint  Meeting,  San  Francisco,  CA,  March  2006. 

O'Brien  KL.  Managing  Patients  with  Rare  Antibodies  and  Multiple  Medical  Issues  is  a  Difficult 
Problem  Requiring  a  Team  Approach.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma, 
WA,  April  2006. 


Department  of  Pediatrics 

Benton  KB.  A  Case  Report  of  an  Isolated,  Midline  Facial  Cutaneous  Appendage:  An  Uncommon 
Example  of  Disorganization  in  Humans.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma, 
WA,  April  2006. 

Cornfeld  RJ.  Juvenile  Arthritis  Presenting  as  a  Soft  Tissue  Mass.  Presented  at  9th  Annual 
Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


28 


Eigner  DJ.  Epstein-Barr  Virus  presenting  as  genital  ulcers.  Presented  at  Uniformed  Services 
Pediatric  Seminar,  Portsmouth,  VA,  March  2006. 

Eigner  DJ.  Epstein-Barr  Virus  Infection  Presenting  as  Genital  Ulcers.  Presented  at  9th  Annual 
Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Fairchok  MP.  Pandemic  Influenza  -  Not  just  for  the  birds.  Presented  at ,  Portsmouth,  VA,  March 
2006. 

Flake  EM.  Aortic  Root  Dilatation  in  a  Patient  with  Overlapping  Osteogenesis  Imperfecta/Ehlers- 
Danlos  Syndrome  Phenotype.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April 
2006. 

Stephan  MJ,  Benton  KB,  Holm  MT,  Gries  DM.  Congenital  Midline  Facial  Cutaneous  Appendage: 
Pathological  Manifestations  of  Disorganization  in  Humans.  Presented  at  XXVII  David  W.  Smith 
Workshop  on  Malformations  and  Morphogenesis,  Lake  Arrowhead,  CA,  September  2006. 


Department  of  Preventive  Medicine 

Moores  CA,  Berke  E,  Cherutich  P,  Reed  S.  Elective  Primary  Cesarean  Delivery  in  Washington 
State:  The  Insurance  Factor.  Presented  at  12th  Annual  Joint  Conference  on  Health  -  Partnering 
for  a  Healthier  Tomorrow,  February  2006. 

Ross  TW.  Hearing  Loss  in  the  Military:  The  Results  of  Deployment  to  a  Combat  Environment. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Ross  TW,  Johnson  R,  Opheim  G.  Informatics  and  STD  surveillance  -  a  software  application  for 
reporting  and  managing  sexually  transmitted  diseases.  Presented  at  Preventive  Medicine  2006, 
Reno,  NV,  February  2006. 

Ross  TW,  Wiesen  AR,  Daniell  W.  Hearing  Loss  in  the  Military:  The  Results  of  Deployment  to  a 
Combat  Environment.  Presented  at  National  Occupational  Research  Agenda  Symposium  2006, 
Washington  DC,  April  2006. 


Department  of  Psychology 

Gahm  GA.  Post-Deployment  Health  Re-Assessment  (PDHRA).  Presented  at  Force  Health 
Protection  2006,  Albuquerque,  NM,  August  2006. 

Gahm  GA,  Meyer  JG,  Miller  JL,  Lucenko  BA.  The  Soldier  Wellness  Assessment  Pilot  Program  at 
Ft.  Lewis.  Presented  at  Force  Health  Protection  2006,  Albuquerque,  NM,  August  2006. 

Lucenko  BA.  Screening  for  Mental  Health  Problems  Following  Deployment.  Presented  at  Society 
for  Traumatic  Stress  Studies,  Toronto,  Canada,  November  2005. 

Peterson  KA,  Knauss  LG.  The  Use  of  Prazosin  in  the  Treatment  of  Combat-Related  Nightmares  in 
Active  Duty  Soldiers.  Presented  at  Albuquerque  Convention  Center,  Albuquerque,  NM,  August 
2006. 


General  Surgery  Service,  Department  of  Surgery 

Arthurs  ZM.  The  Impact  of  Hypothermia  on  Trauma  Care  at  the  31st  Combat  Support  Hospital  in 
Iraq.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Arthurs  ZM.  RAS.  Presented  at  Gary  P.  Wratten  Army  Surgical  Symposium,  Washington,  DC, 
May  2006. 


29 


Arthurs  ZM,  Cuadrado  DG,  Beekley  AC,  Grathwohl  KW,  Sebesta  JA,  Rush  RM.  The  Impact  of 
Hypothermia  on  Trauma  Care  at  the  31st  Combat  Support  Hospital  in  Iraq.  Presented  at  North 
Pacific  Surgical  Association,  Vancouver,  BC,  Canada,  November  2005. 

Beldowicz  BC.  Combat  Vascular.  Presented  at  Gary  P.  Wratten  Army  Surgical  Symposium, 
Washington,  DC,  May  2006. 

Cronk  DR,  Houseworth  TP,  Herbert  GS,  Cuadrado  DG,  Azarow  KS.  Intestinal  Fatty  Acid  Binding 
Protein  (I-FABP)  for  the  Detection  of  Strangulated  Mechanical  Small  Bowel  Obstruction. 

Presented  at  Pacific  Coast  Surgical  Association  77th  Annual  Meeting,  San  Francisco,  CA, 

February  2006. 

Cuadrado  DG.  31st  CSH  Cause  of  Death.  Presented  at  Gary  P.  Wratten  Army  Surgical 
Symposium,  Washington,  DC,  May  2006. 

Eckert  MJ,  Azarow  KS.  Bronchoscopy  in  the  Blast  Injured  Patient.  Presented  at  Pacific  Coast 
Surgical  Association  77th  Annual  Meeting,  San  Francisco,  CA,  February  2006. 

Herbert  GS.  Intraperitoneal  LPS  Delivery  in  Mice  Causes  Multi-organ,  Coordinated  Modulation  of 
SDF-1?  Production  over  a  72-Hour  Period.  Presented  at  9th  Annual  Madigan  Research  Day, 
Tacoma,  WA,  April  2006. 

Herbert  GS.  SDF-1.  Presented  at  Gary  P.  Wratten  Army  Surgical  Symposium,  Washington,  DC, 
May  2006. 

Martin  MJ.  Pediatric  Monitoring.  Presented  at  San  Antonio  Trauma  Symposium,  San  Antonio, 

Tx,  September  2006. 

McGuigan  RM,  Spinella  PC,  Beekley  A,  Sebesta  J,  Perkins  J,  Grathwohl  K,  Azarow  K.  Pediatric 
Trauma:  Combat  Support  Hospital  Experience  in  Iraq.  Presented  at  American  Pediatric  Surgical 
Association,  South  Carolina,  May  2006. 

Mullenix  PS.  MODS.  Presented  at  Gary  P.  Wratten  Army  Surgical  Symposium,  Washington,  DC, 
May  2006. 

Sohn  VY.  Combat  Vascular.  Presented  at  Gary  P.  Wratten  Army  Surgical  Symposium, 
Washington,  DC,  May  2006. 

Sohn  VY,  Rush  RM,  Sebesta  JA,  Beekley  AC,  Gibson  SO,  Azarow  KS,  Koeller  CA,  Meyer  JG. 

From  Buddy-aid  to  the  Forward  Surgical  Team:  The  Madigan  Model  for  Improving  Trauma 
Readiness  of  Brigade  Combat  Teams  Fighting  the  Global  War  on  Terror.  Presented  at  1st  Annual 
Academic  Surgical  Conference,  San  Diego,  CA,  February  2006. 


Ophthalmology  Service,  Department  of  Surgery 

Davis  RW.  LASIK  Flap  Stability  in  Ocular  Trauma.  Presented  at  9th  Annual  Madigan  Research 
Day,  Tacoma,  WA,  April  2006. 

Frazier  TC,  Nelson  ML.  Case  Series  Late  -  Onset  Corneal  Haze  >  10  months  after  Photo 
Retractice  Keratectomy  (PBK)  in  Soldiers  Deployed  to  Afghanistan.  Presented  at  Annual 
Symposium  American  Society,  San  Francisco,  CA,  March  2006. 


Orthopedics  Service,  Department  of  Surgery 

Gloystein  DM.  Developmental  Dislocation  of  the  Hip:  A  Long-Term  Treatment  Outcomes  Study. 
Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


30 


Gloystein  DM,  Grassbaugh  JA,  Arrington  ED.  PCL  Tunnel  Lengths,  An  Anatomic  Study. 
Presented  at  The  American  Academy  of  Orthopaedic  Surgery,  Annual  Meeting,  Chicago,  IL,  March 

2005. 

Guzzo  JA,  Herzog  JP,  Arrington  E,  Devine  J.  A  Retrospective  Review  of  Injuries  Sustained  During 
OIF  and  OEF  Treated  at  a  Tertiary  Military  Medical  Center.  Presented  at  Washington  State 
Chapter  of  American  College  of  Surgeons,  Sun  River,  OR,  June  2006. 

Herzog  JP,  Arrington  ED,  Devine  JG,  Bluman  EM.  A  Field  Expedient  Wound  Vacuum  System. 
Presented  at  Washington  State  Chapter  of  American  College  of  Surgeons,  Sun  River,  OR,  June 

2006. 

Ryan  PM.  The  Role  of  the  Triradiate  Cartilage  in  Predicting  Curve  Progression  in  Adolescent 
Idiopathic  Scoliosis.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


Otolaryngology  Service,  Department  of  Surgery 

Demars  SM.  Perioperative  Immunonutrition  in  Head  and  Neck  Cancer.  Presented  at  9th  Annual 
Madigan  Research  Day,  Tacoma,  WA,  April  2006. 

Demars  SM,  Harsha  WJ,  Crawford  JV.  Effects  of  Smoking  on  Rate  of  Post-Tonsillectomy 
Hemorrhage.  Presented  at  AAO-HNS  Annual  Meeting  &  Oto  Expo,  Toronto,  CA,  September  2006. 

Poss  JM.  Post-Tympanostomy  Swimming  Precautions:  A  Physician  Survey.  Presented  at  AAO- 
HNS  Annual  Meeting  &  Oto  Expo,  Toronto,  Canada,  September  2006. 

Spear  SA.  Review  of  Thyroid  Cancer  Treatment  Outcomes  at  a  Major  Medical  Center  from  1996- 
2000.  Presented  at  AAO-HNS  Annual  Meeting  &  Oto  Expo,  Toronto,  Canada,  September  2006. 

Spear  SA.  Thyroid  Cancer  Treatment  Outcomes  at  a  Major  Medical  Center.  Presented  at  9th 
Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


Urology  Service,  Department  of  Surgery 

DeCastro  BJ.  Five  Year  Follow-up  of  Asymptomatic  Men  found  to  have  Testicular  Microlithiasis 
in  a  Large  Screening  Study.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April 
2006. 

Pugliese  JM.  The  Epidemiology  of  Nephrolithiasis  in  Soldiers  Returning  from  Operation  Iraqi 
Freedom.  Presented  at  9th  Annual  Madigan  Research  Day,  Tacoma,  WA,  April  2006. 


31 


J.  Publications 


Hospital  Dental  Clinic 

Viehweg  TL.  Melanoma  of  the  Oral  and  Maxillofacial  Region.  Oral  and  Maxillofacial  Surgical 
Knowledge  Update  2006. 

Viehweg  TL,  Hudson  JW.  Pneumosinus  dilitans  of  the  Maxillary  Sinuses,  Bilaterally:  A  Case 
Report.  Journal  of  Oral  and  Maxillofacial  Surgery  64(4):  p.  726-30,  2006. 


Department  of  Emergency  Medicine 

Billingsley  RA,  Keilman  CG.  Images  in  Emergency  Medicine:  Fournier's  gangrene.  Ann  Emerg 
Med  47(1):  p.  11,21,  2006. 

Blankenship  RB.  Six  Steps  to  Buying  Your  First  or  Next  PDA.  ACEP  News  2005. 

Brandt  AL,  Tolson  D.  Missed  abdominal  ectopic  pregnancy.  J  Emerg  Med  30(2):  p.  171-4,  2006. 

Johnston  GM,  Denny  MA,  Howden  J.  Herpes  Simplex  Esophagitis  in  an  Immunocompetent  20 
year-old  male.  Resident  and  Staff  Physician  2006. 

Johnston  GM,  Wilson  K,  Harrison  B.  Images  in  Emergency  Medicine:  21  year  old  female  with 
chronic  constipation.  Annals  of  Emergency  Medicine  2006. 

Murphy  CS,  Parsa  T.  Idiopathic  Ovarian  Vein  Thrombosis  a  Rare  Cause  of  Abdominal  Pain.  Am  J 
Emer  Med  24(5):  p.  636-7,  2006. 

Nielson  AS  ,  Kang  CS.  Images  in  emergency  Medicine.  Chokehold  Strangulation.  Ann  Emerg 
Med  47(4):  p.  327,  343,  2006. 

Wedmore  IS,  McManus  JG,  Pusateri  AE,  Holcomb  JB.  A  Special  Report  on  the  Chitosan-based 
Hemostatic  Dressing:  Experience  in  Current  Combat  Operations.  J  Trauma  60(3):  p.  655-8,  2006. 

Wills  BK,  Mycyk  MB,  Mazor  S,  Kanter-Zell  M,  Brace  L,  Erickson  T.  Factitious  Lithium  Toxicity 
Secondary  to  Lithium  Heparin-Containing  Blood  Tubes.  Journal  of  Medical  Toxicology  2(2):  p.  61- 
3,  2006. 


Department  of  Family  Medicine 

Aplund  C,  Webb  C,  Barkdull  T.  Neck  and  back  pain  in  bicycling.  Curr  Sports  Med  Rep  4(5): 
p.  271-4,  2005. 

Edwards  JA.  Disposal  of  Unused  and  Expired  Medications  by  Patients.  NAPCRG  2005. 

Edwards  JA.  Accuracy  and  Precision  of  Ear  Canal  Infrared  Thermometers  in  a  Simulated 
Environment.  NAPCRG  2005. 

Jacoby  G,  Sams  RW  2nd,  Biagioli  F.  Clinical  inquiries.  Should  people  with  a  first-degree  relative 
who  died  from  subarachnoid  hemorrhage  be  screened  for  aneurysms?  Journal  of  Family  Practice 
55(1):  p.  59-60,  2006. 

Junnila  JL,  Cartwright  VW.  Chronic  musculoskeletal  pain  in  children:  part  I.  Initial  evaluation. 
Review.  American  Family  Physician  74(1):  p.  115-22,  2006. 

Junnila  JL,  Cartwright  VW.  Chronic  musculoskeletal  pain  in  children:  part  II.  Rheumatic  causes. 
Review.  American  Family  Physician  74(2):  p.  293-300,  2006. 


32 


Maurer  DM,  Fulton  C,  Doria  M.  Factors  that  influence  the  decision  of  military  dependents  to 
decline  smallpox  vaccination  during  an  outbreak.  Mil  Med.  171(4):  p.  321-4,  2006. 

Oh  RC,  Beresford  SA,  Lafferty  WE.  The  Fish  in  Secondary  Prevention  of  Heart  Disease  (FISH) 
Survey  --  Primary  care  physicians  and  predictors  of  omega-3  fatty  acids  prescribing  behaviors.  J 
Am  Board  Fam  Med  19(5):  p.  459-67,  2006. 

Seehusen  DA,  Baldwin  LM,  Runkle  GP,  Clark  G.  Are  Family  Physicians  Appropriately  Screening 
for  Postpartum  Depression?  Obstet  Gynecol  Surv  60(10):  p.  630-1,  2005. 

Stephens  MB,  Manning  DA,  Arnold-Canuso  A,  Haas  DM.  Maternal  Shoe  Size  and  Infant  Birth 
Weight:  Correlation  or  Fiction?  Am  Board  Family  Medicine  19(4):  p.  426-428,  2006. 

Sullivan  M,  Sams  RW  2nd,  Jamieson  B,  Holt  J.  What  is  the  best  test  to  detect  herpes  in  skin 
lesions?  Journal  of  Family  Practice  55(4):  p.  346  &  348,  2006. 


Graduate  Medical  Eduction 

Jorgensen  JE,  Roth  BJ.  Using  Simulation  in  Medical  Education.  Insight  4(1):  p.  12-3,  2006. 

Roth  BJ.  Common  Chief  Resident  Mistakes.  APDIM:  A  Toolkit  for  Today's  Chief  Medical 
Resident,  14th  Edition  2006. 


Health  Outcomes  Management  Division 

Bingham  MO,  Meyer  JG,  Birgenheier  PS.  Rebuilding  a  Future:  A  Soldier  Readiness  Case 
Management  Program.  USAMEDD  Journal  2005(7):  p.  5-14,  2005. 


Dermatology  Service,  Department  of  Medicine 

Ferguson  JW,  Smith  SB,  Hirota  TK.  Photo  Quiz:  Tungiasis.  Cutis  2006. 


Infectious  Disease  Service,  Department  of  Medicine 

Ake  JA,  Erickson  JC,  Lowry  KJ.  Cerebral  Aneurysmal  Arteriopathy  Associated  with  HIV 
Infection  in  an  adult.  Clinical  Infectious  Diseases  43(5):  p.  e46-50,  2006. 


Internal  Medicine  Service,  Department  of  Medicine 

Michaud  E,  Helwig  M,  Rossman  M,  Glorioso  J,  Salzman  K.  The  Tactical  Electronic  Medical 
Record:  Medical  Operations  in  the  SBCT.  US  Army  Medical  Department  Journal  2005. 


Neurology  Service,  Department  of  Medicine 

Erickson  JC,  Clapp  LE,  Ford  G,  Jabbari  B.  Somatosensory  Auras  in  Refractory  Temporal  Lobe 
Epilepsy.  Epilepsia  47(1):  p.  202-206,  2006. 

Hohler  AD,  Flynn  FG.  Onset  of  Creutzfeldt- Jakob  disease  mimicking  an  acute  cerebrovascular 
event.  Neurology  67(3):  p.  538-9,  2006. 

Joseph  KR,  Ney  JP.  Pediatric  multiple  sclerosis.  Mayo  Clin  Proc  81(2):  p.  151,  2006. 

Ney  JP,  Riechers  RG.  Intramedullary  Spinal  Sarcoidosis:  Clinical  Improvement  Reflected  in  T- 
Lymphocyte  Subpopulation  ratios.  .  Spinal  Cord  44(1):  p.  49-51,  2006. 


33 


Department  of  Nursing 

Kee  CC,  Foley  BJ,  Dudley  W,  Jennings  BM,  Minick  P,  Harvey  SS.  Nursing  structure,  processes, 
and  patient  outcomes  in  army  medical  centers.  West  J  Nurs  Res  27(8):  p.  1040-58,  2005. 

Serna  ED,  McCarthy  MS.  Heads  up  to  prevent  aspiration  during  enteral  feeding.  Nursing  36(1): 
p.  76-7,  2006. 


Hopkins-Chadwick  DL.  The  health  readiness  of  junior  enlisted  military  women:  the  social 
determinants  of  health  model  and  research  questions.  Mil  Med  171(6):  p.  544-9,  2006. 

Prue-Owens  KK.  Use  of  Peripheral  Venous  Access  Devices  for  Obtaining  Blood  Samples  for 
Measurement  of  Activated  Partial  Thromboplastin  Times.  Critical  Care  Nurse  26(#1):  p.  30-38, 
2006. 

Stillsmoking  KL.  Simulation:  Changing  the  Way  Healthcare  Professionals  are  Trained.  Point  of 
View  45(1):  p.  10,  2006. 


Nursing  Research  Service,  Department  of  Nursing 

Jennings  BM,  Loan  LA,  Heiner  SL,  Hemman  EA,  Swanson  KM.  Soldiers'  Experiences  with 
Military  Health  Care.  Military  Medicine  170(12):  p.  999-1004,  2005. 


Department  of  Obstetrics/Gynecology 

Deering  MA,  Heller  J,  McGaha  K,  Heaton  J,  Satin  AJ.  Patients  presenting  with  birth  plans  in  a 
military  tertiary  care  hospital:  a  descriptive  study  of  plans  and  outcomes.  Mil  Med  171(8):  p.  778- 
80,  2006. 

Deering  SH,  Brown  JA,  Hodor  J,  Satin  AJ.  Simulation  training  and  resident  performance  of 
singleton  vaginal  breech  delivery.  Obstet  Gynecol  107(1):  p.  86-9,  2006. 

Elliott  DE,  Patience  TH,  Boyd  E,  Hume  RF,  Calhound  BC,  Napolitano  PG,  Apodaca  CC.  Fetal 
growth  curves  in  an  ethnically  diverse  military  population:  The  AIUM  accredited  platform 
experience.  Mil  Med  171(6):  p.  508-511,  2006. 

Paonessa  DJ,  Napolitano  PG,  Shields  AD,  Celver  J,  Howard  BC,  Gotkin  JL,  Deering  S, 

Hoeldtke  NJ.  The  Effect  of  Cholic  Acid  on  Placental  Artery  Perfusion  Pressure  in  the  Ex-Vivo 
Placental  Cotyledon  Model.  American  Journal  Obstet  Gynecol  193:  p.  S173,  2006. 

Thomson  BA,  Nielsen  PE.  Women's  Health  Care  in  Operation  Iraqi  Freedom:  A  survey  of  camps 
with  echelon  I  or  II  facilities.  Military  Med  171(3):  p.  216-9,  2006. 

VanBlaricom  AL,  Goff  BA,  Chinn  M,  Icasiano  MM,  Nielsen  P,  Mandel  L.  A  New  Curriculum  for 
Hysteroscopy  Training  as  Demonstrated  by  an  Objective  Structured  Assessment  of  Technical  Skill 
(OSATS).  AM  J  Obstet  Gynecol  193(5):  p.  1856-65,  2005. 

Woodman  PJ,  Swift  SE,  O'Boyle  AL,  Valley  MT,  Bland  DR,  Kahn  MA,  Schaffer  JI.  Prevalence  of 
Severe  Pelvic  Organ  Prolapse  in  Relation  to  Job  Description  and  Socioeconomic  Status:  A 
Multicenter  Cross-Sectional  Study.  Int  Urogynecol  J  Pelvic  Floor  Dysfunct  17(4):  p.  340-5,  2006. 


Department  of  Pathology 


34 


Mahlen  SD.  Applications  of  Molecular  Diagnostics  Chapter.  Textbook  of  Diagnostic  Microbiology, 
3rd  Edition  2006. 

O'Brien  KL.  Three  Unusual  Histologic  Variants  of  Fibrous  Papule.  Am  J  Dermatopathol  28(3): 
p.  234,  2006. 

O'Brien  KL,  Chanpeaux  AL.  The  Laboratory  Officer  on  Duty  as  a  Member  of  the  Trauma  Team. 
Transfusion  46(9S):  p.  178,  2006. 

Weppler  EH,  Gaertner  EM.  Malignant  Extragastrointestinal  Stromal  Tumor  Presenting  as  A 
Vaginal  Mass:  Report  of  an  unusual  Case  with  Literature  Review.  International  Journal  of 
Gynecological  Cancer  15(6):  p.  1169-72,  2005. 


Department  of  Pediatrics 

Bondi  SA,  Gries  D,  Faucette  K.  Neonatal  Euthanasia?  Pediatrics  117(3):  p.  983-4,  2006. 

Braun  LE,  Tsuchida  T,  Spiegel  H.  Meningoencephalitis  in  a  child  complicated  by  myocarditis, 
quadriparesis  and  respiratory  failure.  Pediatr  Infect  Dis  J.  25(9):  p.  853,  855-6,  2006. 

Cartwright  VW,  Beitz  L.  Rheumatic  Diseases  and  Their  Treatments.  Pediatric  Critical  Care 
3(91):  . 

Davis  BE,  Shurtleff  DB,  Walker  WO,  Seidel  KD,  Duguay  S.  Acquisition  of  autonomy  skills  in 
adolescents  with  myelomeningocele.  Dev  Med  Child  Neurol  48(4):  p.  253-8,  2006. 

Erdie-Lalena  CR,  Holm  VA,  Kelly  PC,  Frayo  RS,  Cummings  DE.  Gherlin  Levels  in  Young 
Children  with  Prader-Willi  Syndrome.  J  Pediatrics  149(2):  p.  199-204,  2006. 

Harsha  WT,  Kalandarova  E,  McNutt  PM,  Irwin  RG,  Noel  JM.  Nutritional  Supplementation  with 
TGFib,  Glutamine  and  Short  Chain  Fatty  Acids  Minimizes  Methotrexate-Induced  Injury.  J  Pediatr 
Gastroenterol  Nutr  42(1):  p.  53-8,  2006. 

Maranich  AM,  Hamele  M,  Fairchok  MP.  Atlanto-Axial  Subluxation:  A  Newly  Reported 
Trampolining  Injury.  Clinical  Pediatrics  (Phila)  45(5):  p.  468-70,  2006. 

Stephan  MJ.  A  Tribute  to  Our  Teacher,  Dr.  Judith  Hall:  A  Child  with  the  Trait  of  the  Earl  of 
Shrewbury.  Am  J  Med  Genet  A.  140(2):  p.  156-9,  2006. 

Szabo  Z,  Crepeau  MW,  Mitchell  AL,  Stephan  MJ,  Puntel  RA,  Loke  YK,  Kirk  RC,  Urban  Z.  Aortic 
Aneurysmal  Disease  and  Cutis  Laxa  Caused  by  Defects  in  the  Elastin  Gene.  J  Med  Genet  43(3): 
p.  255-258,  2006. 

Walter  EB,  Neuzil  KM,  Zhu  Y,  Fairchok  MP,  Gagliano  ME,  Monto  AS,  Englund  JA.  Influenza 
vaccine  immunogenicity  in  6-  to  23-month-old  children:  are  identical  antigens  necessary  for 
priming?  Pediatrics  118(3):  p.  e570-8,  2006. 


Physical  Medicine  &  Rehabilitation  Service 

Greer  MA,  Essenberg  EM,  Weaver  SH.  A  Review  of  41  Upper  Extremity  War  Injuries  and  the 
Protective  Gear  Worn  during  Operation  Enduring  Freedom  &  Operation  Iraqi  Freedom.  Military 
Medicine  171(7):  p.  595-7,  2006. 


Department  of  Psychiatry 

Doyle  ME,  Peterson  KA.  Re-entry  and  reintegration:  Returning  Home  after  combat.  Psychiatr  Q 
76(4):  p.  361-70,  2005. 


35 


Department  of  Radiology 

Reidman  DA,  Balingit  AG.  Paradoxic  technetium-99  methylene  diphosphonate  localization  in 
malignant  mesothelioma.  Clin  Nucl  Med  31(2):  p.  71-3,  2006. 

Ronsivalle  JA,  Statler  JD,  Venbrux  AC,  Arepally  A.  Intravascular  bullet  migration:  A  report  of 
two  cases.  Mil  Med  170(12):  p.  1044-7,  2005. 


General  Surgery  Service,  Department  of  Surgery 

Arthurs  ZM,  Cuadrado  DG,  Beekley  AC,  Grathwohl  KWA,  Perkins  J,  Rush  RM,  Sebesta  J.  The 
impact  of  hypothermia  on  trauma  care  at  the  31st  combat  support  hospital.  Am  J  Surg  191(5): 
p.  610-4,  2006. 

Arthurs  ZM,  Kjorstad  R,  Mullenix  P,  Rush  RM  Jr,  Sebesta  J,  Beekley  A.  The  use  of  damage- 
control  principles  for  penetrating  pelvic  battlefield  trauma.  Am  J  Surg  191(5):  p.  604-9,  2006. 

Beekley  AC.  United  States  military  surgical  response  to  modern  large-scale  conflicts:  the  ongoing 
evolution  of  a  trauma  system.  Surg  Clin  North  Am  86(3):  p.  689-709,  2006. 

Cronk  DR,  Houseworth  TP,  Cuadrado  DG,  Herbert  GS,  McNutt  PM,  Azarow  KS.  Intestinal  fatty 
acid  binding  protein  (I-FABP)  for  the  detection  of  strangulated  mechanical  small  bowel 
obstruction.  Curr  Surg  63(5):  p.  322-5,  2006. 

Eckert  MJ,  Clagett  CL,  Martin  MJ,  Azarow  KS.  Bronchoscopy  in  the  blast  injury  patient.  Arch 
Surg  141(8):  p.  806-9;  discussion  810-1,  2006. 

Martin  MJ,  FitzSullivan  E,  Salim  A,  Brown  CV,  Demetriades  D,  Long  W.  Discordance  between 
lactate  and  base  deficit  in  the  surgical  intensive  care  unit:  which  one  do  you  trust?  Am  J  Surg. 
191(5):  p.  625-30,  2006. 

Martin  MJ,  McDonald  JM,  Mullenix  PS,  Steele  SR,  Demetriades  D.  Operative  management  and 
outcomes  of  traumatic  lung  resection.  J  Am  Coll  Surg  203(3):  p.  336-44,  2006. 

Martin  RF,  Rush  RM.  Chapter.  Surgical  Clinics  of  North  America  86(3):  p.  785,  2006. 

McGuigan  RM,  Azarow  KS.  Congenital  Chest  Wall  Defects.  Surg  Clinical  North  AM  86(2):  p.  353- 
70,  2006. 

McGuigan  RM,  Mullenix  PS,  Vegunta  R,  Pearl  R,  Sawin  R,  Azarow  KA.  Splanchnic  Perfusion 
pressure:  A  better  predictor  of  safe  primary  closure  than  intraabdominal  pressure  in  neonatal 
gastroschisis.  J  Pediatric  Surg  41(5):  p.  901-04,  2006. 

Mullenix  PS,  Martin  MJ,  Steele  SR,  Hadro  NC,  Peterson  RP,  Anderson  CA.  Rapid  High  Volume 
Population  Screening  for  Three  Major  Risk  Factors  of  Future  Stroke:  Phase  I  Results.  Vase 
Endovasc  Surg  40(3):  p.  177-87,  2005. 

Mullenix  PS,  McDonald  JM,  Miller  J,  Needham  CS.  Modified  Sternotomy  to  Minimize  Infection 
Risk  in  Patients  with  Prior  Laryngectomy  and  Permanent  Tracheostomy.  J  Card  Surg  2006  21(4): 
p.  403-6,  2006. 

Mullenix  PS,  Steele  SR,  Andersen  CA,  Starnes  BW,  Salim  A,  Martin  MJ.  Limb  salvage  and 
outcomes  among  patients  with  traumatic  popliteal  vascular  injury:  an  analysis  of  the  National 
Trauma  Data  Bank.  Journal  of  Vascular  Surgery  44(1):  p.  94-100,  2006. 

Rush  RM.  Surgical  support  for  low-intensity  conflict,  limited  warfare,  and  special  operations. 
Surgical  Clinics  of  North  America  86(3):  p.  727-52,  2006. 

Steele  SR,  Madoff  RD.  Systematic  review:  The  treatment  of  anal  fissure.  Aliment  Pharmacol  Ther 
24(2):  p.  247-57,  2006. 


36 


Steele  SR,  Martin  MJ,  Mullenix  PS,  Azarow  KS,  Andersen  CA.  The  significance  of  incidental 
thyroid  abnormalities  identified  during  carotid  duplex  ultrasonography.  Archives  of  Surgery 
141(10):  p.  981-5,  2005. 


Otolaryngology  Service,  Department  of  Surgery 

Baumgartner  BJ,  Backous  DD.  Radiology  quiz  case  1.  Postinflammatory  fibrosis  of  the  EAC 
(medial  canal  fibrosis).  Arch  Otolaryngol  Head  Neck  Surg  132(6):  p.  690,692,  2006. 

Baumgartner  BJ,  Peterson  KL.  A  glottic  wood  chip  presenting  as  chronic  dysphonia:  report  of  a 
case  and  review  of  the  literature.  Arch  Otolaryngol  Head  Neck  Surg  132(1):  p.  98-100,  2006. 

Kelsch  TA,  Schaefer  LA,  Esquivel  CR.  Vestibular  evoked  myogenic  potentials  in  young  children: 
test  parameters  and  normative  data.  Laryngoscope  116(6):  p.  895-900,  2006. 


Urology  Service,  Department  of  Surgery 

Pugliese  JM,  Peterson  AC,  Philbrick  JH  Jr,  Allen  RC  Jr.  Ureteral  endometriosis  in  patients  after 
total  abdominal  hysterectomy:  Presentation  and  diagnosis:  A  case  series.  Urology  67(3): 
p.  622.el3-5,  2006. 

Raj  GV,  Peterson  AC,  Webster  GD.  Outcomes  Following  Erosions  of  the  Artificial  Urinary 
Sphincter.  Urology  175:  p.  2186-2190,  2006. 


Vascular  Surgery,  Department  of  Surgery 

Roukis  TS.  Determining  the  insertion  site  for  retrograde  intramedullary  nail  fixation  of 
tibiotalocalcaneal  arthrodesis:  A  radiographic  and  intraoperative  anatomical  landmark  analysis.  J 
Foot  Ankle  Surg  45(4):  p.  227-34,  2006. 

Roukis  TS,  Zgonis  T.  The  management  of  acute  Charcot  fracture-dislocations  with  the  Taylor's 
spatial  external  fixation  system.  Clin  Podiatr  Med  Surg  23(2):  p.  467-83,  viii,  2006. 

Roukis  TS,  Zgonis  T.  Minimally  invasive  "pinless"  external  fixation  for  foot  and  ankle 
reconstruction.  .  Orthopedics  29(3):  p.  209-12,  2006. 

Roukis  TS,  Zgonis  T,  Tiernan  B.  Autologoous  platelet-rich  plasma  for  wound  and  osseous  healing: 
A  review  of  the  literature  and  commercially  available  products.  Adv  Ther  23(2):  p.  218-37,  2006. 

Starnes  BW.  Peacekeeping  and  Stability  Operations:  A  Military  Surgeon's  Perspective.  Surgical 
Clinics  of  North  America  86(3):  p.  753-63,  2006. 

Starnes  BW,  Andersen  CA,  Ronsivalle  JA,  Stockmaster  NR,  Mullenix  PS,  Statler  JD.  Totally 
percutaneous  aortic  aneurysm  repair:  Experience  and  prudence.  J  Vase  Surg  43(2):  p.  270-6,  2006. 

Starnes  BW,  Arthurs  ZM.  Endovascular  management  of  vascular  trauma.  Perspect  Vase  Surg 
Endovasc  Ther  18(2):  p.  114-29,  2006. 

Starnes  BW,  Beekley  AC,  Sebesta  JA,  Andersen  CA,  Rush  RM  Jr.  Extremity  vascular  injuries  on 
the  battlefield:  Tips  for  surgeons  eploying  to  war.  J  Trauma  60(2):  p.  432-42,  2006. 


37 


K.  Exempt  Protocols  approved  in  FY  2006  (no  detailed  summary  sheet) 


Number 

PI 

Dept/Serv 

Protocol  Title 

206090 

LaVan  JT 

FM 

Identification  of  Health  Factors  Associated  with  Perceived 
Quality  of  Life  in  an  Aging  Population 

206017 

Saguil  AA 

FM 

Physician  Perception  of  the  Impact  of  a  Morning  Report 
Educational  Intervention 

206046 

Hopkins-Chadwick  DL 

Nurs 

A  Descriptive  Study  of  Military  Women's  Information  Needs 
for  Sexual  Health  Promotion 

206007 

Guidry  BA 

OB 

Screening  for  Depression  at  Postpartum  Appointments 

206005 

Han  JJ 

OB 

Accuracy  of  Office  Endometrial  Biopsy:  Comparison  of 
Biopsy  and  Hysterectomy  Findings 

206001 

Sessions  DC 

OB 

Birth  Weight  and  Macrosomia:  Army  Versus  Navy  in  the 
Puget  Sound 

206003 

Shen-Gunther  J 

OB 

Cancer  Genetic  Testing:  Referral  Patterns  and  Outcomes 

206065 

Whitacre  RM 

Path 

Post  Approval  Surveillance  Study  of  Platelet  Outcomes, 
Release  Tested 

206060 

Eichinger  JK 

Surg/Orth 

Analysis  of  Failure  Characteristics  of  Fixed  Locking  Plates 
With  and  Without  Screw-  Hole  Inserts:  A  Biomechanical 
Study 

206089 

Schweinberger  MH 

Surg/V  as 

Foot  Care  Knowledge  of  Diabetic  Patients  in  a  Military 
Medical  Center 

38 


L.  Detail  Summary  Sheets 


Table  of  Contents  for  Detail  Summary  Sheets 


Legend: 

S  =  Status  [0  -  Ongoing,  C  -  Completed,  E  -  Expired,  T  -  Terminated] 

T  =  Protocol  Type  [A  -  Animal,  B  -  Bench,  C  -  Cancer,  L  -  Local,  M  -  Multicenter] 


Prin.  Invest.  S  T  Title 

#Protocol  No. 

DEPARTMENT  OF  ANESTHESIA  &  OPERATIVE  SERVICES 


Miller  JP 
#206121 

0 

M 

Comparison  of  Direct  Versus  Indirect  Laryngeal  Views  using  the 
Video  Laryngoscope  During  Standard  Intubation  Procedures 

Miller  JP 
#204010 

C 

L 

Evaluation  of  the  Combat  Medic  Skills  Validation  Test 

DEPARTMENT  OF  CLINICAL  INVESTIGATION 

Bullock  JM 
#203122 

E 

A 

Establishment  of  a  Limb  Regeneration  Program  Using 
Notophthalmus  viridescens  (newt)  as  the  Model  Organism  and  the 
Creation  of  a  Transgenic  N.  viridescens  Strain 

Bullock  JM 
#206122 

0 

A 

Profiling  of  Proteins  Extracted  from  Tissue  Taken  from 

Regenerating  and  Intact  Notophthalmus  viridescens  Limbs  Using 
SELDI 

Hartenstine  MJ 
#205031 

0 

L 

Proteomic  Analysis  of  Longitudinally-Collected  Maternal  Plasma 
Samples:  Establishing  the  'Pregnancy  Proteome' 

McNutt  PM 
#205044 

0 

L 

A  Prospective  Study  of  Pseudocholinesterase  Activity  in  Patients 
with  Fibromyalgia,  Chronic  Pain,  Pelvic  Pain  and  Hernias 

Merrill  NL 
#203092 

E 

A 

Animal  Tissue  Use  in  Biomedical  Research  and  Training 

Merrill  NL 
#206109 

0 

A 

Animal  Tissue  Use  in  Biomedical  Research  and  Training 

Merrill  NL 
#203076 

T 

A 

Breeding  Colony  of  Red-Spotted  Newt  (Notophthalmus  viridescens) 

Merrill  NL 
#206091 

0 

A 

MAMC  Rodent  and  Rabbit  Quality  Assurance  and  Sentinel  Program 

Merrill  NL 
#203075 

T 

A 

Mouse  (Mus  Musculus)  Breeding  Protocol 

HOSPITAL  DENTAL  CLINIC 

Burgan  SC 
#203116 

0 

M 

Host  Response  Gene  203014  in  Military  Populations 

DEPARTMENT  OF  EMERGENCY  MEDICINE 

Cooper  JL 
#204087 

T 

L 

A  Prospective  Study  on  the  Effects  of  Ginkgo  Biloba  on  Bleeding 
Times 

Denny  MA 
#206063 

0 

L 

A  Randomized  Study  of  Capnography  in  Emergency  Department 
Procedural  Sedation 

Denny  MA 
#206050 

T 

L 

Magnesium  Sulfate  for  the  Prevention  of  Etomidate  Induced 
Myoclonus  in  Emergency  Department  Procedural  Sedation 

39 


Prin.  Invest.  S  T  Title 

#Protocol  No. 


Johnston  GM 
#206028 


C  L  Application  of  the  Wells  Criteria  to  determine  Pretest  Probability  of 
Pulmonary  Embolism:  A  Retrospective  Review  of  the  practices  of 
the  Madigan  Army  Medical  Center  Department  of  Emergency 
Medicine 


Nielson  AS 
#206059 


0  L  Causes  and  consequences  of  patients  who  left  a  busy  Army  Medical 
Center  Emergency  Department  prior  to  evaluation  by  a  qualified 
health  care  provider 


Younggren  BN 
#206078 


O  A  Emergency  Medicine/Combat  Trauma  Management  Training  Using 
Animal  Models  (Domestic  Goat/  Capra  hircus,  Pig/Sus  scrofa) 

DEPARTMENT  OF  FAMILY  MEDICINE 


Clark  GW 
#205133 


O  L  Prevalence  of  Hypertension  in  Active  Duty  Service  Members 


Crosland  T 
#205124 

Flynn  DM 
#204117 

Flynn  DM 
#206105 

Kelly  KM 
#205130 

Kimmer  SL 
#206019 


O  L  Racial  Differences  in  Health  Outcomes  for  Adults  with  Diabetes  in  a 
Military  Setting 

O  L  Impact  of  the  Sole  Prescriber  Program  on  use  of  Opioid  Medications 
and  Quality  of  Life 

O  L  Implementation  of  an  Office-Based  Screening  Tool  to  Improve 

Adherence  with  Recommended  Preventive  Services  in  Primary  Care 

O  L  Use  of  Pedometers  Among  Healthcare  Providers  in  a  Large  Military 
Family  Medicine  Department 

C  L  Pediatric  Obesity  in  a  Military  Family  Medicine  Clinic 


Maurer  DM 
#206048 


Pflipsen  MC 
#205025 

Rosen  IM 
#206067 


O  L  A  Randomized,  Controlled  Trial  of  Manual/Manipulative  Therapy 
for  Acute  Low  Back  Pain  in  Active  Duty  Military  Personnel:  A  Pilot 
Study 

C  L  Prevalence  of  Vitamin  B12  Deficiency  in  the  Type  2  Diabetic 
Population 

C  L  Determinants  of  Military  Medical  Student  Interest  in  Family 
Medicine 


Saguil  AA 
#205103 

Sams  RW 
#206104 


C  M  The  Role  of  Evidence  and  Other  Determinants  in  Resident 
Discussions  of  Spirituality  with  Patients 

O  L  Implementing  a  Medical  Ethics  Curriculum  in  a  Family  Medicine 
Residency:  Assessment  of  Need,  Description  of  the  Process,  and 
Evaluation  of  Effectiveness 


Short  MW 
#205132 

Short  MW 
#205131 

Short  MW 
#206080 


C  L  Colonoscopy  by  a  Family  Physician:  A  Case  Series  Demonstrating 
Healthcare  Savings 

C  L  Esophagogastroduodenoscopy  by  a  Family  Physician:  A  Case  Series 
Demonstrating  Healthcare  Savings 

O  L  Predicting  Intern  Performance  using  an  Objective  Structured 
Clinical  Examination 


GRADUATE  MEDICAL  EDUCATION 

Boden  JH  O  L 


#205090 


Attitudes  and  Perceptions  of  Refractive  Surgery  Among  ROTC 
Cadets  Presenting  for  a  Flight  Physical  and  Self-Reported  Barriers 
Towards  Having  Refractive  Surgery  to  Correct  Visual  Acuity  and 
Becoming  Medically  Qualified  for  Army  Aviation 


HEALTH  OUTCOMES  MANAGEMENT  DIVISION 

Meyer  JG  O  L  The  Deployment  of  Physical  Therapy  for  Combat:  A  Description  of 

#205108  the  Process  and  Outcomes 


40 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


CARDIOLOGY  SERVICE,  DEPARTMENT  OF  MEDICINE 

Schachter  DT  0  L  CardioSEAL  Septal  Occlusion  System  (HUD) 

#202300 

Schachter  DT  0  L  Jostent  Coronary  Stent  Graft  (HUD) 

#201300 

HEMATOLOGY/ONCOLOGY  SERVICE,  DEPARTMENT  OF  MEDICINE 

Brown  TA  O  S  CTSU  E5202:  A  Randomized  Phase  III  Study  Comparing  5-FU, 

#206113  Leucovorin  and  Oxaliplatin  versus  5-FU,  Leucovorin,  Oxaliplatin 

and  Bevacizumab  in  Patients  with  Stage  II  Colon  Cancer  at  High 
Risk  for  Recurrence  to  Determine  Prospectively  the  Prognostic 
Value  of  Molecular  Markers 


Daniels  JT 
#206023 


Daniels  JT 
#205094 


O  M  A  Multi-Center,  Randomized,  Phase  3  Study  of  Iodine  1-131 

Tositumomab  Therapeutic  Regimen  Versus  Ibritumomab  Tiuxetan 
Therapeutic  Regimen  for  Subjects  with  Relapsed  or  Transformed 
Follicular  Non-Hodgkin's  Lymphoma 

T  M  A  Randomized,  Open-Label  Trial  Comparing  Two  Avastin™ 

(Bevacizumab)-Based  Treatment  Regimens  For  The  First-Line 
Treatment  Of  Metastatic  Colorectal  Cancer 


Daniels  JT 
#206103 


T  M  Phase  3,  Multicenter,  Multi-National,  Open-Label  Study  to  Evaluate 
the  Safety  and  Efficacy  of  Alfimeprase  in  Subjects  with  Occluded 
Central  Venous  Access  Devices 


Daniels  JT 
#205007 


Daniels  JT 
#89080 


Daniels  JT 
#90027 


S  M  PSOC  2003:  A  Phase  II  Study  Evaluating  the  Efficacy  of 

Gemcitabine,  Carboplatin,  Dexamethasone  and  Rituximab  for 
Previously  Treated  Lymphoid  Malignancies,  UW  Protocol  Number 
LYM.03.01 

T  S  SWOG  8814  (ECOG  4188,  NCCTG  883051):  Phase  III  Comparison  of 
Adjuvant  Chemoendocrine  Therapy  with  CAF  and  Concurrent  or 
Delayed  Tamoxifen  to  Tamoxifen  Alone  in  Postmenopausal  Patients 
with  Breast  Cancer  Having  Involved  Axillary  Nodes  and  Positive 
Hormone  Receptors 

O  S  SWOG  8851  (EST  5811,  INT-0101):  Phase  III  Comparison  of 

Combination  Chemotherapy  (CAF)  and  Chemohormonal  Therapy 
(CAF  +  Zoladex  or  CAF  +  Zoladex  +  Tamoxifen)  in  Premenopausal 
Women  with  Axillary  Node-Positive,  Receptor-  Positive  Breast 
Cancer 


Daniels  JT 
#90029 


T  S  SWOG  8897  (EST-2188,  CALGB-8897,  INT-0101):  Phase  III 

Comparison  of  Adjuvant  Chemotherapy  With  or  Without  Endocrine 
Therapy  in  High-Risk,  Node  Negative  Breast  Cancer  Patients,  and  a 
Natural  History  Follow-up  Study  in  Low-Risk,  Node  Negative 
Patients 


Daniels  JT 
#90056 


Daniels  JT 
#97096 


C  S  SWOG  8997  (ECOG  3887):  Phase  III  Chemotherapy  of  Disseminated 
Advanced  Stage  Testicular  Cancer  with  Cisplatin  Plus  Etoposide 
with  Either  Bleomycin  or  Ifosfamide 

O  S  SWOG  9059  (E1392,  INT-0126):  Phase  III  Comparison  of  Standard 
Radiotherapy  versus  Radiotherapy  plus  Simultaneous  Cisplatin, 
versus,  split- Course  Radiotherapy  plus  Simultaneous  Cisplatin  and 
5-Fluorouracil,  in  Patients  with  Unresectable  Squamous  Cell 
Carcinoma  of  the  Head  and  Neck 


41 


Prin.  Invest.  S  T  Title 

#Protocol  No. 


Daniels  JT 
#93032 


Daniels  JT 
#93097 

Daniels  JT 
#93136 


Daniels  JT 
#93166 

Daniels  JT 
#94170 


Daniels  JT 
#95003 


Daniels  JT 
#95093 


Daniels  JT 
#94163 

Daniels  JT 
#96095 


Daniels  JT 
#96118 

Daniels  JT 
#98112 


Daniels  JT 
#99014 


Daniels  JT 
#200036 


Daniels  JT 
#99071 


0  S  SWOG  9061  (EST-2190,  INT  0121):  A  Phase  III  Study  of 

Conventional  Adjuvant  Chemotherapy  vs  High  Dose  Chemotherapy 
and  Autologous  Bone  Marrow  Transplantation  or  Stem  Cell 
Transplantation  as  Adjuvant  Intensification  Therapy  Following 
Conventional  Adjuvant  Chemotherapy  in  Patients  with  Stage  II  and 
III  Breast  Cancer  at  High  Risk  of  Recurrence 

O  S  SWOG  9205:  Central  Prostate  Cancer  Serum  Repository  Protocol 

O  S  SWOG  9221,  MDACC  ID  91-025,  INT- 191-001:  Phase  III  Double- 

Blind  Randomized  Trial  of  13-Cis  Retinoic  Acid  (13-cRA)  to  Prevent 
Second  Primary  Tumors  (SPTs)  in  Stage  I  Non-Small  Cell  Lung 
Cancer 

O  S  SWOG  9303:  Phase  III  Study  of  Radiation  Therapy,  Levamisole,  and 
5-Fluorouracil  versus  5-Fluorouracil  and  Levamisole  in  Selected 
Patients  With  Completely  Resected  Colon  Cancer 

T  S  SWOG  9313:  Phase  III  Comparison  of  Adjuvant  Chemotherapy  With 
High-Dose  Cyclophosphamide  +  Doxorubicin  vs  Sequential 
Doxorubicin  Followed  by  Cyclophosphamide  in  High-Risk  Breast 
Cancer  Patients  with  0-3  Positive  Nodes 

O  S  SWOG  9401:  A  Controlled  Phase  III  Evaluation  of  5-FU  Combined 
with  Levamisole  and  Leucovorin  as  Surgical  Adjuvant  Treatment 
Following  Total  Gross  Resection  of  Metastatic  Colorectal  Cancer 

O  S  SWOG  9402:  Phase  III  Intergroup  Randomized  Comparison  of 

Radiation  Alone  vs  Pre-Radiation  Chemotherapy  for  Pure  and  Mixed 
Anaplastic  Oligodendrogliomas 

O  S  SWOG  9410  (INT  0148):  Doxorubicin  Dose  Escalation,  With  or 

Without  Taxol,  As  Part  of  the  CA  Adjuvant  Chemotherapy  Regimen 
for  Node  Positive  Breast  Cancer:  A  Phase  III  Intergroup  Study 

O  S  SWOG  9514:  Phase  III  Double-Blind,  Placebo-Controlled, 

Prospective  Randomized  Comparison  of  Adjuvant  Therapy  with 
Tamoxifen  vs.  Tamoxifen  &  Fenretinide  in  Postmenopausal  Women 
with  Involved  Axillary  Lymph  Nodes  and  Positive  Receptors, 
Intergroup 

O  S  SWOG  9515:  Phase  III  Intergroup  Trial  of  Surgery  Followed  by  (1) 
Radiotherapy  vs.  (2)  Radiochemotherapy  for  Resectable  High  Risk 
Squamous  Cell  Carcinoma  of  the  Head  and  Neck 

O  S  SWOG  C9581:  Phase  III  Randomized  Study  of  Adjuvant 

Immunotherapy  with  Monoclonal  Antibody  17-lA  Versus  No 
Adjuvant  Therapy  Following  Resection  for  Stage  II  (Modified  Astler- 
Coller  B2)  Adenocarcinoma 

O  S  SWOG  C9741:  A  Randomized  Phase  III  Trial  of  Sequential 
Chemotherapy  Using  Doxorubicin,  Paclitaxel,  and 
Cyclophosphamide,  or  Concurrent  Doxorubicin  and 
Cyclophosphamide  Followed  by  Paclitaxel  at  14  or  21  Day  Intervals 
in  Women  with  Node  Positive  Stage  II/IIIA  Breast  Cancer 

O  S  SWOG  E1199:  A  Phase  III  Study  of  Doxorubicin- Cyclophosphamide 
Therapy  Followed  by  Paclitaxel  or  Docetaxel  Given  Weekly  or  Every 
3  Weeks  in  Patients  with  Axillary  Node-Positive  Breast  Cancer 

O  S  SWOG  E2197:  Phase  III  Study  of  Adriamycin/Taxotere  vs. 

Adriamycin/Cytoxan  for  the  Adjuvant  Treatment  of  Node  Positive  or 
High  Risk  Node  Negative  Breast  Cancer 


42 


Prin.  Invest.  S  T  Title 

#Protocol  No. 


Daniels  JT 
#204066 

Daniels  JT 
#200040 


Daniels  JT 
#202010 


Daniels  JT 
#202012 


Daniels  JT 
#97070 


Daniels  JT 
#99040 

Daniels  JT 
#200120 


Daniels  JT 
#201136 


Daniels  JT 
#201137 


Daniels  JT 
#203084 


Daniels  JT 
#204052 


Daniels  JT 
#204123 


0  S  SWOG  E2496  Randomized  Phase  III  Trial  of  ABVD  Versus  Stanford 
V  +/-  Radiation  Therapy  in  Locally  Extensive  and  Advanced  Stage 
Hodgkin's  Disease  With  0-2  Risk  Factors 

O  S  SWOG  E4494:  Phase  III  Trial  of  CHOP  versus  CHOP  and  Chimeric 
Anti-CD20  Monoclonal  Antibody  (IDEC-C2B8)  in  Older  Patients 
with  Diffuse  Mixed,  Diffuse  Large  Cell  and  Immunoblastic  Large 
Cell  Histology  Non-Hodgkin's  Lymphoma 

O  S  SWOG  E5597:  Phase  III  Chemoprevention  Trial  of  Selenium 

Supplementation  in  Persons  with  Resected  Stage  I  Non- Small  Cell 
Lung  Cancer 

O  S  SWOG  GO  182:  A  Phase  III  Randomized  Trial  of  Paclitaxel  and 

Carboplatin  Versus  Triplet  or  Sequential  Doublet  Combinations  in 
Patients  with  Epithelial  Ovarian  or  Primary  Peritoneal  Carcinoma 

O  S  SWOG  JBR.  10  (NCIC  CTG  BR.  10):  A  Phase  III  Prospective 

Randomized  Study  of  Adjuvant  Chemotherapy  with  Vinorelbine  and 
Cisplatin  in  Completely  Resected  Non-small  Cell  Lung  Cancer  with 
Companion  Tumour 

O  S  SWOG  JMA.  17:  A  Phase  III  Randomized  Double-Blinded  Study  of 
Letrozole  Versus  Placebo  in  Women  with  Primary  Breast  Cancer 
Completing  Five  or  More  Years  of  Adjuvant  Tamoxifen 

O  S  SWOG  N9831:  Phase  III  Trial  of  Doxorubicin  and 

Cyclophosphamide  (AC)  Followed  by  Weekly  Paclitaxel  With  or 
Without  Trastuzumab  as  Adjuvant  Treatment  for  Women  with 
HER-2  Over-expressing  or  Amplified  Node  Positive  or  High-Risk 
Node  Negative  Breast  Cancer  (an  Intergroup  Study) 

C  S  SWOG  S0009:  A  Phase  II  Evaluation  of  Neoadjuvant 

Chemotherapy,  Interval  Debulking  Followed  by  Intraperitoneal 
Chemotherapy  in  Women  with  Stage  III  and  IV  Epithelial  Ovarian 
Cancer,  Fallopian  Tube  Cancer  or  Primary  Peritoneal  Cancer 

O  S  SWOG  S0012:  A  Comparative  Randomized  Study  of  Standard 

Doxorubicin  and  Cyclophosphamide  Followed  by  Weekly  Paclitaxel 
Vs.  Weekly  Doxorubicin  and  Daily  Oral  Cyclophosphamide  Plus  G- 
CSF  Followed  by  Weekly  Paclitaxel  as  Neoadjuvant  Therapy  for 
Inflammatory  and  Locally  Advanced  Breast  Cancer 

O  S  SWOG  S0016,  A  Phase  III  Trial  of  CHOP  +  Rituximab  vs.  CHOP  + 
Iodine-131-Labeled  Monoclonal  Anti-Bl  Antibody  (Tositumomab)  for 
Treatment  of  Newly  Diagnosed  Follicular  Non-Hodgkin's 
Lymphomas 

C  S  SWOG  S0023,  A  Phase  III  Trial  of  Cisplatin/Etoposide/Radiotherapy 
with  Consolidation  Docetaxel  Followed  by  Maintenance  Therapy 
with  ZD  1839  or  Placebo  in  Patients  With  Inoperable  Locally 
Advanced  Stage  III  Non-Small  Cell  Lung  Cancer 

O  S  SWOG  S0106,  A  Phase  III  Study  of  the  Addition  of  Gemtuzumab 
Ozogamicin  (Mylotarg®)  Induction  Therapy  Versus  Standard 
Induction  With  Daunomycin  and  Cytosine  Arabinoside  Followed  by 
Consolidation  and  Subsequent  Randomization  to  Post-Consolidation 
Therapy  With  Gemtuzumab  Ozogamicin  (Mylotarg®)  or  No 
Additional  Therapy  for  Patients  Under  Age  56  With  Previously 
Untreated  DeNovo  Acute  Myeloid  Leukemia  (AML) 


43 


Prin.  Invest. 
#Protocol  No. 

Daniels  JT 
#204034 


Daniels  JT 
#204094 

Daniels  JT 
#204064 


Daniels  JT 
#206068 

Daniels  JT 
#91094 

Daniels  JT 
#99019 

Daniels  JT 
#205035 

Daniels  JT 
#200084 


Daniels  JT 
#202074 

McCune  DE 
#204073 


McCune  DE 
#205093 


McCune  DE 
#206014 

McCune  DE 
#205016 


McCune  DE 
#205087 


McCune  DE 
#205070 


S  T  Title 

0  S  SWOG  S0221,  Phase  III  Trial  of  Continuous  Schedule  AC  +  G  Vs.  Q 
2  Week  Schedule  AC,  Followed  by  Paclitaxel  Given  Either  Every  2 
Weeks  or  Weekly  for  12  Weeks  as  Post-Operative  Adjuvant  Therapy 
in  Node-Positive  or  High-Risk  Node-Negative  Breast  Cancer 

O  S  SWOG  S0226,  Phase  III  Randomized  Trial  of  Anastrozole  Versus 
Anastrozole  and  Fulvestrant  as  First  Line  Therapy  for  Post 
Menopausal  Women  With  Metastatic  Breast  Cancer 

O  S  SWOG  S0230,  Phase  III  Trial  of  LHRH  Analog  Administration 
During  Chemotherapy  to  Reduce  Ovarian  Failure  Following 
Chemotherapy  in  Early  Stage,  Hormone-  Receptor  Negative  Breast 
Cancer 

O  S  SWOG  S0520:  Phase  II  Study  of  PXD101  (NSC-726630)  in  Relapsed 
and  Refractory  Aggressive  B-Cell  Lymphomas 

O  S  SWOG  S9007  (ECOG  S9007),  Cytogenetic  Studies  in  Leukemia 
Patients 

O  S  SWOG  S9808:  Long-Term  Follow-Up  Protocol:  An  Administrative 
Tool 

O  S  SWOG  S9910  Leukemia  Centralized  Reference  Laboratories  and 
Tissue  Repositories,  Ancillary 

O  S  SWOG  S9921:  Adjuvant  Androgen  Deprivation  versus  Mitoxantrone 
plus  Prednisone  plus  Androgen  Deprivation  in  Selected  High  Risk 
Prostate  Cancer  Patients  Following  Radical  Prostatectomy,  Phase 

III 

O  S  SWOG  S9925  Lung  Cancer  Specimen  Repository  Protocol,  Ancillary 

O  M  A  Multicenter,  Randomized,  Phase  III  Study  of  Rituximab  versus 
Iodine  I  131  Tositumomab  Therapeutic  Regimen  for  Patients  with 
Relapsed  Follicular  Non-Hodgkin's  Lymphoma,  Protocol  CCBX001- 
049 

O  M  A  Phase  3,  Double-Blind,  Placebo-Controlled  Study  of  Maintenance 
Premetrexed  plus  Best  Supportive  Care  versus  Best  Supportive 
Care  Immediately  Following  Induction  Treatment  for  Advanced 
Non-Small  Cell  Lung  Cancer  AND  COMPANION  STUDY 
Companion  Translational  Research  Protocol 

O  M  A  Phase  I/II  Trial  of  Zometa  in  Patients  with  Monoclonal 
Gammopathy  of  Undetermined  Significance  (MGUS) 

T  M  A  Phase  II  Multicenter,  Randomized,  Double-blind,  Placebo- 

controlled  Dose-Ranging,  Parallel  Group  Study  of  the  Safety  and 
Efficacy  of  the  Oral  Neurokinin- 1  Receptor  Antagonist,  GW679769, 
When  Administered  as  50mg,  lOOmg,  and  150mg  Oral  Tablets  in 
Combination  with  Ondansetron  Hydrochloride  and  Dexamethasone 
for  the  Prevention  of  Chemotherapy-Induced  Nausea  and  Vomiting 
in  Cancer  Subjects  Receiving  Moderately  Emetogenic  Chemotherapy 

S  M  A  Phase  II,  Open  Label,  Multi-center  Study  of  EP2 101  Therapeutic 
Vaccine  in  Patients  with  Stage  Illb,  Stage  IV,  or  Recurrent  Non- 
Small  Cell  Lung  Cancer  (NSCLC) 

O  M  A  Phase  II  Study  Using  Alemtuzumab  Combined  with  Fludarabine 
for  the  Treatment  of  Relapsed/Refractory  B-cell  Chronic 
Lymphocytic  Leukemia  (B-CLL) 


44 


Prin.  Invest. 
#Protocol  No. 

McCune  DE 
#206126 

McCune  DE 
#204114 

McCune  DE 
#204006 


McCune  DE 
#204044 

McCune  DE 
#204096 


McCune  DE 
#202083 


McCune  DE 
#204107 


McCune  DE 
#202114 


McCune  DE 
#202089 


McCune  DE 
#204124 


McCune  DE 
#202088 


McCune  DE 
#204072 


S  T  Title 

0  L  A  Phase  II  Trial  of  Imatinib  (Gleevec)  Plus  Gemcitabine  In  Patients 
With  Ovarian  Carcinoma  Who  Have  Failed  At  Least  One  Prior 
Chemotherapy 

O  M  A  Phase  II  Trial  of  Weekly  Docetaxel  plus  Every  3-Week 

Carboplatin  in  Patients  with  Stage  IIIB/IV  Non-small  Cell  Lung 
Cancer,  Protocol  GIA  12156 

T  M  A  Phase  III,  Randomized,  Double-blinded  Efficacy  and  Safety  Study 
of  Three  Doses  of  TAS-108  Administrated  Orally  in  Postmenopausal 
Patients  with  Locally  Advanced  or  Locally  Recurrent  Inoperable  or 
Progressive  Metastatic  Breast  Carcinoma  Following  Standard  First 
Line  Endocrine  Therapy,  Protocol  Number  TAS 108-0004 

O  M  A  Phase  III  Study  of  Delayed  vs.  Immediate  Second-line  Therapy 
with  Docetaxel  after  Gemcitabine  +  Carboplatin  in  Advanced  Non- 
Small  Cell  Lung  Cancer,  Protocol  Number  B9E-US-S245 

CM  A  Randomized,  Open-Label  Study  of  PROCRIT®  (Epoetin  Alfa) 
Initiated  at  40,000  Units  Every  Week  Versus  80,000  Units  Every 
Two  Weeks  In  Anemic  Patients  With  Cancer  Receiving 
Chemotherapy,  Protocol  PR03-27-064 

O  M  A  Randomized  Phase  III  Trial  of  Gemzar  versus  Doxil  with 

Crossover  Treatment  Option  for  Patients  with  Platinum-Resistant 
Ovarian,  Fallopian  Tube  or  Primary  Peritoneal  Cancer  Undergoing 
Second  or  Third-Line  Chemotherapy,  Protocol  Number:  B9E-US- 
S301 

S  S  CTSU  ACOSOG-Z9001,  A  Phase  III  Randomized  Double-blind  Study 
of  Adjuvant  STI571  (Gleevec™)  Versus  Placebo  in  Patients 
Following  the  Resection  of  Primary  Gastrointestinal  Stromal  Tumor 
(GIST) 

O  S  CTSU  CALGB  40101,  Cyclophosphamide  and  Doxorubicin  (CA)  (4 
VS  6  Cycles)  versus  Paclitaxel  (4  VS  6  Cycles)  as  Adjuvant  Therapy 
for  Women  with  0-3  Positive  Axillary  Lymph  Nodes:  A  2X2  Factorial 
Phase  III  Randomized  Study 

O  S  CTSU  CALGB  49907,  A  Randomized  Trial  of  Adjuvant 

Chemotherapy  With  Standard  Regimens,  Cyclophosphamide, 
Methotrexate  and  Fluorouracil  -  (CMF)  or  Doxorubicin  and 
Cyclophosphamide  -  (AC),  Versus  Capecitabine  in  Women  65  Years 
and  Older  with  Node  Positive  or  Node  Negative  Breast  Cancer 

C  S  CTSU  CALGB  80303,  A  Randomized  Phase  III  Trial  of  Gemcitabine 
plus  Bevacizumab  (NSC  #704865  IND  #7921)  Versus  Gemcitabine 
plus  Placebo  in  Patients  With  Advanced  Pancreatic  Cancer 

O  S  CTSU  E1A00  A  Randomized  Phase  III  Trial  of  Thalidomide  (NSC 
#66847)  Plus  Dexamethasone  versus  Dexamethasone  in  Newly 
Diagnosed  Multiple  Myeloma 

C  S  CTSU  E3201  Intergroup  Randomized  Phase  III  Study  of 

Postoperative  Irinotecan,  5 -Fluorouracil  and  Leucovorin  vs 
Oxaliplatin,  5 -Fluorouracil  and  Leucovorin  vs  5 -Fluorouracil  and 
Leucovorin  for  Patients  with  Stage  II  or  III  Rectal  Cancer  Receiving 
Either  Preoperative  Radiation  and  5 -Fluorouracil  or  Postoperative 
Radiation  and  5 -Fluorouracil 


45 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


McCune  DE 
#204043 


McCune  DE 
#204035 

McCune  DE 
#205071 


McCune  DE 
#202043 


McCune  DE 
#206112 


McCune  DE 
#206054 


McCune  DE 
#206073 


McCune  DE 
#204008 

McCune  DE 
#206084 


McCune  DE 
#204080 


McCune  DE 
#202107 


McCune  DE 
#206055 


McCune  DE 
#206013 


0  S  CTSU  IBCSG  Trial  25-02,  Tamoxifen  and  Exemestane  Trial  (TEXT), 
A  Phase  III  Trial  Evaluating  the  Role  of  Exemestane  Plus  GnRH 
Analogue  as  Adjuvant  Therapy  for  Premenopausal  Women  with 
Endocrine  Responsive  Breast  Cancer 

O  S  CTSU  NCIC  CTG  MA.27,  A  Randomized  Phase  III  Trial  of 

Exemestane  Versus  Anastrozole  in  Postmenopausal  Women  With 
Receptor  Positive  Primary  Breast  Cancer 

T  S  CTSU  NSABP  80101  Phase  III  Intergroup  Trial  of  Adjuvant 

Chemoradiation  after  Resection  of  Gastric  or  Gastroesophageal 
Adenocarcinoma 

O  S  CTSU  RTOG  98-04:  Phase  III  Trial  of  Observation  +/-  Tamoxifen  vs. 
RT  +/-  Tamoxifen  for  Good  Risk  Duct  Carcinoma  In-Situ  (DCIS)  of 
the  Female  Breast 

O  G  CTSU/GOG  0218  A  Phase  III  Trial  of  Carboplatin  and  Paclitaxel 
Plus  Placebo  Versus  Carboplatin  and  Paclitaxel  Plus  Concurrent 
Bevacizumab  (NSC  #704865,  IND  #7921)  Followed  By  Placebo, 
Versus  Carboplatin  and  Paclitaxel  Plus  Concurrent  and  Extended 
Bevacizumab,  In  Women  With  Newly  Diagnosed,  Previously 
Untreated,  Suboptimal  Advanced  Stage  Epithelial  Ovarian  and 
Primary  Peritoneal  Cancer 

O  M  NSABP  B-38  A  Phase  III  Adjuvant  Trial  Comparing  Three 

Chemotherapy  Regimens  in  Women  with  Node-Positive  Breast 
Cancer:  Docetaxel/Doxorubicin/Cyclophosphamide  (TAC);  Dose- 
Dense  (DD)  Doxorubicin/Cyclophosphamide  Followed  by  DD 
Paclitaxel  (DD  AC-P);  DD  Doxorubicin/Cyclophosphamide  Followed 
by  DD  Paclitaxel  Plus  Gemcitabine  (DD  AC-PG) 

O  M  Phase  1/2  study  of  ZK-Epothilone  (ZK-Epo;  ZK  219477)  in 

combination  with  carboplatin  in  patients  with  platinum-sensitive, 
recurrent  ovarian  cancer 

O  M  Phase  II  Trial  of  ONTAK®  in  Refractory  or  Relapsed  Advanced  Non¬ 
small  Cell  Lung  Cancer  (NSCLC) 

O  M  Pilot  Study  to  Evaluate  the  Safety  and  Efficacy  of  PROCRIT 
(Epoetin  alfa)  80,000  Units  Once  Every  Four  Weeks  (Q4W)  vs. 
40,000  Units  Once  Every  Two  Weeks  (Q2W)  in  Cancer  Patients  with 
Non-Chemotherapy  Anemia 

O  M  Protocol  U2963n:  The  National  Lymphocare  Study:  An 

Observational  Study  of  Treatment,  Outcomes,  and  Prognosis  in 
Patients  With  Follicular  Non-Hodgkin's  Lymphoma 

C  L  Randomized  Study  of  Docetaxel  Versus  Docetaxel  Plus 

GenasenseTM  (G3139;  Bcl-2  Antisense  Oligonucleotide)  in  Patients 
with  Previously  Treated  Non- Small  Cell  Lung  Cancer,  No.  N304 

O  S  SWOG  S0424:  Molecular  Epidemiology  Case-Series  Study  of  Non- 
Small  Cell  Lung  Cancer  in  Smoking  and  Non-Smoking  Women  and 
Men 

O  S  SWOG  S0435  A  Phase  II  Trial  of  BAY  43-9006  (SNC-724772)  in 
Patients  with  Platinum-Treated  Extensive  Stage  Small  Cell  Lung 
Cancer 


46 


Prin.  Invest. 
#Protocol  No. 


Title 


S  T 


Mysliwiec  AG 
#205036 


Mysliwiec  AG 
#206025 


0  S  CTSU  NSABP  C-08,  A  Phase  III  Clinical  Trial  Comparing  Infusional 
5-Fluorouracil  (5-FU),  Leucovorin,  And  Oxaliplatin  (mFOLFOX6) 
Every  Two  Weeks  With  Bevacizumab  To  The  Same  Regimen 
Without  Bevacizumab  For  The  Treatment  Of  Patients  With 
Resected  Stages  II  And  III  Carcinoma  of  the  Colon 

T  M  RegistHER:  An  Observational  Cohort  Study  of  Patients  with  HER2- 
Positive  Metastatic  Breast  Cancer 


Ramsdell  MJ 
#204082 


O  L  Evaluating  Cognitive  Function  in  Women  Receiving  Chemotherapy 
for  Newly  Diagnosed  Breast  Cancer 


INTERNAL  MEDICINE  SERVICE,  DEPARTMENT  OF  MEDICINE 


Avalos  C 
#205046 


O  L  The  Effect  of  Blood  Transfusion  on  Serum  Ferritin  and  Iron 


Bauler  KC 
#205123 

DeHaan  PJ 
#205039 


Evans  NR 
#206119 

Fischer  CJ 
#206064 


O  L  Current  Use  and  Complications  of  Peripherally  Inserted  Central 
Catheters  (PICC):  A  Retrospective  Study 

O  L  Management  of  Parapneumonic  Effusions:  Does  Following 

Pneumonia  Treatment  Guidelines  Affect  Outcome?  A  Retrospective 
Study 

O  L  Urinary  Markers  of  Renal  Injury  and  N- Acetylcysteine  Efficacy 
(URINE) 

C  L  Does  Participation  in  a  Subspecialty  Elective  Rotation  Improve  the 
Respective  American  Board  of  Internal  Medicine  Subspecialty 
Score? 


Kiley  CA 
#205104 

Kwon  HP 
#206087 


C  L  Appropriate  Use  of  CTPA  in  the  Evaluation  of  Pulmonary  Embolism 
-  An  Examination  of  Hospital-Wide  Referral  Practices 

O  L  Hemoptysis  in  Young  Adults 


Kwon  HP 
#206069 

Mount  GR 
#205038 

Short  PA 
#202048 


O  L  The  Effects  of  Nighttime  Low  Dose  Aspirin  on  Ambulatory  Blood 
Pressure  Testing  in  Treated  Hypertensive  Patients 

T  L  Effect  of  A  Single  Intra-articular  Steroid  Injection  on  Serum 

Fructosamine  Levels  in  Patients  with  Type  2  Diabetes  Mellitus 

O  M  A  Multinational,  Randomized,  Double-blind,  Placebo-controlled, 
Forced-titration,  2X2  Factorial  Design  Study  of  the  Efficacy  and 
Safety  of  Long  Term  Administration  of  Nateglinide  and  Valsartan  in 
the  Prevention  of  Diabetes  and  Cardiovascular  Outcomes  in  Subjects 
with  Impaired  Glucose  Tolerance  (IGT),  Protocol  No.  CDJN608 
B2302 


Short  PA 
#204045 


Wang  JY 
#205004 


O  M  A  Prospective,  multinational,  multicenter,  double-blind,  randomized, 
active-controlled  trial  to  compare  the  effects  of  Lotrel 
(amlodipine/benazepril)  to  benazepril  and  hydrochlorothiazide 
combined  on  the  reduction  of  cardiovascular  morbidity  and  mortality 
in  patients  with  high  risk  hypertension,  Protocol  No.  CCIB002I2301: 
ACCOMPLISH  (Avoiding  Cardiovascular  Events  through 
COMbination  Therapy  in  Patients  Living  with  Systolic 
Hypertension) 

C  L  Efficacy  of  Iron  in  Restless  Legs  Syndrome  (RLS)  Patients  With 
Low-Normal  Ferritin:  A  Randomized,  Double-Blind,  Placebo 
Controlled  Study 


NEPHROLOGY  SERVICE,  DEPARTMENT  OF  MEDICINE 

Lee  JY  C  L  Does  High  Resistive  Index  by  Doppler  Ultrasonography  Predict 

#205121  Small  Kidney  Sizes? 


47 


Prin.  Invest.  S  T  Title 

#Protocol  No. 


NEUROLOGY  SERVICE,  DEPARTMENT  OF  MEDICINE 


Erickson  JC 
#204062 

Erickson  JC 
#203048 

Erickson  JC 
#206075 

Erickson  JC 
#203097 


Erickson  JC 
#205107 

Erickson  JC 
#205118 

Erickson  JC 
#205115 


O  L  A  Randomized  Trial  of  a  Migraine  Management  Seminar  in  the 
Treatment  of  Migraines 

O  L  A  Randomized  Trial  of  B  Vitamins  for  Alzheimer's  Disease 

O  L  Association  Between  Migraine  and  Psychiatric  Conditions  In 

Soldiers  Returning  from  Combat 

O  M  CLOSURE  I  Trial:  A  Prospective,  Multicenter,  Randomized, 

Controlled  Trial  to  Evaluate  the  Safety  and  Efficacy  of  the 
STARFlex  Septal  Closure  System  Versus  Best  Medical  Therapy  in 
Patients  with  a  Stroke  and/or  Transient  Ischemic  Attack  Due  to  a 
Presumed  Paradoxical  Embolism  Through  a  Patent  Foramen  Ovale 

C  L  Diagnosis  and  Treatment  of  Migraines  in  U.S.  Army  Soldiers 

O  L  Prevalence  and  Impact  of  Migraine  Among  Deployed  Soldiers 


O  M  Study  of  Acute  Viprinex™  for  Emergency  Stroke:  A  Randomized, 
Double-Blind,  Placebo-Controlled  Study  of  Viprinex™  (Ancrod 
Injection)  in  Subjects  Beginning  Treatment  within  6  Hours  of  the 
Onset  of  Acute,  Ischemic  Stroke 

PULMONARY  DISEASE  &  CRITICAL  CARE  SERVICE,  DEPARTMENT  OF  MEDICINE 


Caras  WE 
#205032 

Clagett  CL 
#206083 


Mysliwiec  V 
#206086 

Niven  AS 
#205128 


T  L  Adjunctive  Role  of  Mirtazapine  in  Mild  Positional  Sleep  Apnea 

T  M  A  Randomized,  Double-blind,  Placebo-controlled,  Parallel  Group, 
Stratified,  Multi-center,  12  Week  Study  Comparing  the  Safety  and 
Efficacy  of  Fluticasone  and  Formoterol  Combination  (FlutiForm™ 
100/10  meg  twice  daily)  in  a  Single  Inhaler  (SkyePharma  HFA 
pMDI)  with  the  Administration  of  Placebo  or  Fluticasone  (100  meg 
twice  daily)  and  Formoterol  (10  meg  twice  daily)  Alone  in  Adolescent 
and  Adult  Patients  with  Mild  to  Moderate  Asthma 

O  L  Identifying  Adherence  Obstacles  to  CPAP  Therapy 

O  L  Impulse  Oscillometry  and  Obstructive  Lung  Disease:  Assessment  of 
a  Clinically  Significant  Bronchodilator  Response 


NUTRITION  CARE  DIVISION 


Cates-Gorang  CC 
#206008 


O  L 


Attenuation  of  Exertional  Muscle  Damage  with  a  Nutritional 
Supplement 

DEPARTMENT  OF  NURSING 


DePew  CL 
#206093 

Jones  JM 
#203030 

Loan  LA 
#205117 

Loan  LA 
#202066 


O  L  Effects  on  Aspirated  Volume,  Patency,  and  Tracheal  Mucosa  using 
High  Intermittent  Negative  Pressure  versus  Low  Continuous 
Negative  Pressure  for  Subglottic  Secretion  Aspiration 

C  L  Junior  Army  Nurse  Corps  Officers'  Perceptions,  Experiences  and 
Expectations  of  Head  Nurse  Leadership 

O  L  A  Qualitative  Descriptive  Study  that  Identifies  Essential 

Competencies  and  Leadership  Characteristics  of  Army  Adult 
Medical- Surgical  Critical  Care  Head  Nurses  (dissertation) 

O  L  Caring  Interventions  for  Couples  Who  Have  Miscarried 


48 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


Loan  LA 
#205037 

Loan  LA 
#204084 


Loan  LA 
#204031 

Loan  LA 
#201104 


O  L  Determining  the  Effectiveness  of  a  Stroke  Prevention  Program 

O  L  Impact  of  Inpatient  Physician  Order  Entry  on  Medication 

Administration  and  Dispensing  Error  Rates  in  the  Neonatal 
Intensive  and  Intermediate  Care  Units 

O  M  Military  Nursing  Outcomes  Database:  Analysis  &  Expansion 
(MilNOD  IV) 

O  L  Newborn  Infant  Speech  Perception 


Loan  LA 
#202075 

McNabb  LA 
#206108 

Trego  LL 
#206107 


O  L  Secondary  Analysis  of  NICU  Modified  Care  Environment  Projects 

O  L  Army  Nurse  Corps  Officers'  Deployment  Experiences  and 
Reintegration 

O  L  Menstruation  During  Deployment:  Women's  Attitudes  Towards 
Menstrual  Suppression 


Trego  LL  C  L  Military  Women's  Thoughts  about  Menstruation  and  Menstrual 

#206002  Suppression  During  Deployment 

ANESTHESIA  STUDENTS,  DEPARTMENT  OF  NURSING 

Hannon  MK  C  L  Efficacy  of  Preoperative  Valerian  (Night  Before)  on  Day  of  Surgery 

#204112  Anxiety 

DEPARTMENT  OF  OBSTETRICS/GYNECOLOGY 


Burris  AC 
#206042 


C  L  Resident  Training  in  Assessment  of  the  Sexual  Assault  Patient 
Utilizing  Simulation 


Chinn  MK 
#205140 


O  L  Continuous  Use  of  the  Oral  Contraceptive  for  Menstrual  Cycle 

Suppression  and  the  Effects  on  Bone  Density;  a  Prospective, 
Randomized,  Clinical  Trial 


Dainty  LA  O  G  GOG  0041:  Surgical  Staging  of  Ovarian  Carcinoma 

#81035 


Dainty  LA 
#81105 


Dainty  LA 
#84033 


O  G  GOG  0052:  A  Phase  III  Randomized  Study  of  Cyclophosphamide 
Plus  Adriamycin  Plus  Platinol  Versus  Cyclophosphamide  Plus 
Platinol  in  Patients  with  Optimal  Stage  II  Ovarian  Adenocarcinoma 

O  G  GOG  0072:  Ovarian  Tumors  of  Low  Malignant  Potential:  A  Study  of 
the  Natural  History  and  a  Phase  II  Trial  of  Melphalan  and 
Secondary  Treatment  with  Cisplatin  in  Patients  with  Progressive 
Disease 


Dainty  LA 
#84074 


Dainty  LA 
#86089 


Dainty  LA 
#87104 


O  G  GOG  0078:  Evaluation  of  Adjuvant  VP-16,  Bleomycin,  and  Cisplatin 
(BEP)  Therapy  in  Totally  Resected  Choriocarcinoma,  Endodermal 
Sinus  Tumor,  Embryonal  Carcinoma  and  Grade  3  Immature 
Teratoma  of  the  Ovary,  Pure  and  Mixed  with  Other  Elements 

O  G  GOG  0085:  A  Randomized  Comparison  of  Hydroxyurea  versus  5-FU 
Infusion  and  Bolus  Cisplatin  as  an  Adjuvant  to  Radiation  Therapy 
in  Patients  with  Stages  II-B,  III,  and  IV-A  Carcinoma  of  the  Cervix 
and  Negative  Para-Aortic  Nodes 

O  G  GOG  0092:  Treatment  of  Selected  Patients  with  Stage  IB 

Carcinoma  of  the  Cervix  After  Radical  Hysterectomy  and  Pelvic 
Lymphadenectomy:  Pelvic  Radiation  Therapy  versus  No  Further 
Therapy 


49 


Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Dainty  LA 
#87028 

0 

G 

GOG  0095:  Randomized  Clinical  Trial  for  the  Treatment  of  Women 
with  Selected  Stage  IC  and  II  (A,B,C)  and  Selected  IAi  and  IBi  and 
IAii  and  IBii  Ovarian  Cancer,  Phase  III 

Dainty  LA 
#87091 

0 

G 

GOG  0099:  A  Phase  III  Randomized  Study  of  Adjunctive  Radiation 
Therapy  in  Intermediate  Risk  Endometrial  Adenocarcinoma 

Dainty  LA 
#93063 

0 

G 

GOG  0123:  A  Randomized  Comparison  of  Radiation  Therapy  & 
Adjuvant  Hysterectomy  vs  Radiation  Therapy  &  Weekly  Cisplatin  & 
Adjuvant  Hysterectomy  in  Patients  with  Bulky  Stage  IB  Carcinoma 
of  the  Cervix 

Deering  SH 
#206029 

0 

L 

Simulation  Training  for  Postpartum  Hemorrhage 

Flood  SK 
#206098 

0 

L 

Serum  Estradiol  Levels  in  Patients  with  Polycystic  Ovarian 
Syndrome  undergoing  Ovulation  Induction  with  Clomiphene  Citrate 

Han  JJ 
#99077 

c 

L 

Misoprostol  for  the  Medical  Management  of  Non-viable  First 
Trimester  Pregnancies 

Hill  DL 
#204111 

0 

M 

Glyburide  Compared  to  Insulin  in  the  Management  of  White's 
Classification  A2  Gestational  Diabetes 

Hill  DL 
#206099 

0 

L 

Molecular  mechanisms  of  progesterone  mediated  inhibition  of  LPS 
and  other  inflammatory  agent  induced  production  of  pro- 
inflammatory  cytokines  in  the  fetal-maternal  circuitry  of  the  human 
placenta 

Howard  BC 
#203067 

0 

L 

The  Effects  of  IL-10  on  the  Production  of  Inflammatory  Cytokines  in 
a  Placental  Artery  Explant  Model 

Howard  BC 
#203066 

0 

L 

The  Production  of  Immunoregulatory  Cytokines  in  a  Placental 
Artery  Explant  Model 

Howard  BC 
#204088 

0 

M 

Use  of  Transvaginal  Cervical  Length  Measurements  in  Twin 
Gestations 

Lattu  AL 
#205005 

0 

L 

The  Distribution  of  Bishop  Scores  and  Quantitative  Values  of  Fetal 
Fibronectin  (fFN)  in  Nulliparous  Patients  Between  37-42  Weeks 
Gestation:  A  Prospective  Observational  Study 

Lattu  AL 
#203078 

0 

L 

Use  of  Pipelle  Endometrial  Sampling  in  the  Evaluation  of  Abnormal 
First  Trimester  Pregnancy 

Manshande  MM 
#205089 

0 

L 

Pilot  Study  of  a  Novel  Cord  Blood  Collection  Technique 

Napolitano  PG 
#203045 

0 

M 

Randomized  Controlled  Trial  of  Endurance  Exercise  and 

Gallbladder  Disease  Risk  in  Overweight  Pregnant  Women 

Napolitano  PG 
#203001 

0 

B 

The  Effect  of  Magnesium  on  Matrix  Metalloproteinase-9  Activity  in 
Umbilical  Cord  Blood  at  Delivery  of  Pregnancies  Complicated  by 
Chorioamnionitis 

Napolitano  PG 
#203099 

0 

L 

Umbilical  Cord  Plasma  Homocysteine  Concentrations  at  Delivery  in 
Pregnancies  Complicated  by  Preeclampsia 

Paonessa  DJ 
#204108 

c 

L 

The  Effects  of  Cholic  Acid  and  Deoxycholic  Acid  on  Placental  Artery 
Perfusion  Pressures  in  the  Ex  Vivo  Placental  Cotyledon  Model 

Zalucki  CM 
#205021 

0 

L 

Correlation  of  Persistent  Anal  Sphincter  Defects  and  Symptoms 
following  Repair  of  Anal  Sphincter  Lacerations  due  to  Obstetric 
Injury  in  Primiparous  Women 

50 


Prin.  Invest.  S  T  Title 

#Protocol  No. 

DEPARTMENT  OF  PATHOLOGY 


Ager  EP 
#203095 

T 

M 

Implementation  of  the  SARS  Coronavirus  Real-Time  PCR  Primers 
and  Probes  Assay  to  Detect  SARS  Coronavirus  in  Respiratory 
Specimens 

Ager  EP 
#203041 

0 

M 

Use  of  a  Non-FDA  Approved  Gene  Amplification  Test  To  Detect  or 
Rule-Out  Vaccinia  in  Patients  With  Complications  Following 
Smallpox  Vaccination  or  Possible  Contact  Vaccinia 

Andrews  JM 
#205102 

0 

L 

Absolute  Lymphocytosis  in  Adults:  A  Laboratory  Protocol 

Champeaux  AL 
#205042 

0 

L 

Incidental  Anatomic  and  Histologic  Findings  in  Bariatric  Surgery 
Specimens 

DEPARTMENT  OF  PEDIATRICS 

Cason  RL 
#203014 

T 

L 

Clinical  Use  of  Reticulocyte  Hemoglobin  to  Detect  Iron  Deficiency  at 
the  12  Month  Well  Baby  Visit 

Davis  BE 
#204104 

0 

M 

Health,  Quality  of  Life  &  Activity  in  Cerebral  Palsy 

Davis  BE 
#204074 

0 

M 

Survey  of  Chronic  Pain  and  Its  Effects  on  Youth  With  Disabilities 

Ervin  MK 
#206049 

0 

L 

An  Observational  Study  to  Determine  the  Factors  Influencing  Bone 
Mineral  Density  in  Post-Menarchal  Adolescents  with 

Neuromuscular  Disabilities 

Fairchok  MP 
#205138 

0 

M 

Evaluation  of  Serologic  Responses  to  Fluzone®  in  Infants  >  6 

Months  of  Age  Who  Did  or  Did  Not  Receive  Fluzone  Vaccine  at  2 
Months  of  Age 

Fairchok  MP 
#203052 

c 

M 

Improving  the  Delivery  of  Influenza  Vaccine  to  Young  Children:  A 
Comparison  of  Two  Influenza  Vaccine  Regimens 

Fairchok  MP 
#205137 

T 

M 

Safety  and  Immunogenicity  of  Fluzone®  Influenza  Virus  Vaccine 
(2005-2006  Formulation)  Among  Healthy  Children  6  to  12  Weeks  of 
Age 

Fairchok  MP 
#205034 

c 

M 

Safety  and  Immunogenicity  of  Influenza  Virus  Vaccine  Fluzone® 
2004-2005  Among  Healthy  Children  2  Months  vs  6  Months  of  Age 

Fairchok  MP 
#205139 

0 

L 

The  Impact  of  Human  Metapneumo virus  Versus  other  Common 
Respiratory  Viruses  in  Infants  in  Fulltime  Daycare 

Fitzgerald  KL 
#206035 

0 

M 

Military  Children  at  Risk  -  Enhancing  Quality  of  Life  (mCARE) 
Needs  Assessment 

Gries  DM 
#205065 

0 

L 

Staphylococcus  Aureus  Intestinal  Colonization  Among  Healthy 
Infants 

Harsha  WT 
#204097 

T 

A 

Effect  of  Immunomodulatory  Diet  Upon  5-Fluorouracil  Induced  Oral 
and  Intestinal  Mucostitis  in  Golden  Syrian  Hamsters  (Mesocricetus 
auratus) 

Johnson  ER 
#206021 

0 

L 

EKG  Screening  in  ROTC  Cadets;  Is  It  Useful? 

Kramer  LC 
#203119 

0 

L 

Alternating  Antipyretics:  Antipyretic  Efficacy  Of  Acetaminophen 
Versus  Acetaminophen  Alternated  With  Ibuprofen  In  Children 

Lieuw  KH 
#205110 

0 

C 

AALL03N1,  Understanding  the  Ethnic  and  Racial  Differences  in 
Survival  in  Children  with  Acute  Lymphoblastic  Leukemia 

51 


Prin.  Invest. 
#Protocol  No. 

Lieuw  KH 
#206052 


Lieuw  KH 
#206095 

Lieuw  KH 
#206096 

Lieuw  KH 
#206051 


Lieuw  KH 
#206097 

Lieuw  KH 
#200032 

Lieuw  KH 
#200077 

Lieuw  KH 
#200139 


Lieuw  KH 
#205015 

Lieuw  KH 
#205068 

Lieuw  KH 
#205095 

Lieuw  KH 
#205067 

Lieuw  KH 
#205026 


Lieuw  KH 
#205122 


Lieuw  KH 
#206034 


Lieuw  KH 
#205084 


Lieuw  KH 
#203024 


Lieuw  KH 
#205047 


S  T  Title 

0  C  ACNS0331  A  Study  Evaluating  Limited  Target  Volume  Boost 

Irradiation  and  Reduced  Dose  Craniospinal  Radiotherapy  (18.00  Gy) 
and  Chemotherapy  in  Children  with  Newly  Diagnosed  Standard 
Risk  Medulloblastoma:  A  Phase  III  Double  Randomized  Trial 

0  C  AEWS02B1,  A  Group  wide  Biology  and  Banking  Study  for  Ewing 
Sarcoma 

0  C  AHOD0431,  A  Phase  III  Study  for  the  Treatment  of  Children  and 
Adolescents  with  Newly  Diagnosed  Low  Risk  Hodgkin  Disease 

O  M  ANBL0032  Phase  III  Randomized  Study  Of  Chimeric  Antibody 
14.18  (Chl4.18)  In  High  Risk  Neuroblastoma  Following 
Myeloablative  Therapy  And  Autologous  Stem  Cell  Rescue 

O  C  AREN03B2;  Renal  Tumors  Classification,  Biology,  and  Banking 
Study 

C  C  COG  9900,  ALinC  17,  Classification  (C),  B-Precursor  Induction 
Treatment  (I)  Protocol 

O  C  COG  9904,  ALinC  17:  Treatment  for  Patients  with  Low  Risk  Acute 
Lymphoblastic  Leukemia,  A  Phase  III  Study 

O  C  COG  A5971:  Randomized  Phase  III  Study  for  the  Treatment  of 
Newly  Diagnosed  Disseminated  Lymphoblastic  Lymphoma  or 
Localized  Lymphoblastic  Lymphoma,  A  Phase  III  COG  Study 

O  C  COG  AALL0031,  A  COG  Pilot  Study  for  the  Treatment  of  Very  High 
Risk  Acute  Lymphoblastic  Leukemia  in  Children  and  Adolescents 

O  C  COG  AALL0232,  High  Risk  B-precursor  Acute  Lymphoblastic 
Leukemia 

O  C  COG  AALL0331,  Standard  Risk  B-precursor  Acute  Lymphoblastic 
Leukemia;  A  Phase  III  Group-Wide  Study 

O  C  COG  AALL03B1,  Classification  of  Acute  Lymphoblastic  Leukemia 

C  C  COG  AAML03P1,  Treatment  of  Newly  Diagnosed  Childhood  Acute 
Myeloid  Leukemia  (AML)  Using  Intensive  MRC-Based  Therapy  and 
Gemtuzumab  Ozogamicin  (GMTZ):  A  COG  Pilot  Study 

C  C  COG  ACNS0126,  A  Phase  II  Study  of  Temozolomide  in  the 

Treatment  of  Children  with  High-grade  Glioma  or  diffuse  intrinsic 
Pontine  Gliomas 

O  C  COG  ACNS0423:  A  Phase  II  Study  of  Concurrent  Radiation  and 

Temozolomide  Followed  by  Temozolomide  and  Lomustine  (CCNU)  in 
the  Treatment  of  Children  with  High  Grade  Glioma 

O  C  COG  AGCT0132,  A  Phase  III  Study  of  Reduced  Therapy  in  the 
Treatment  of  Children  with  Low  and  Intermediate  Risk 
Extracranial  Germ  Cell  Tumors 

O  C  COG  AHOD0031,  A  Phase  III  Group-wide  Study  of  Dose-intensive 
Response-based  Chemotherapy  and  Radiation  Therapy  for  Children 
and  Adolescents  with  Newly  Diagnosed  Intermediate  Risk  Hodgkin 
Disease 

C  C  COG  AHOD00P1,  A  Pilot  Study  of  Re-Induction  Chemotherapy  with 

Ifosfamide,  and  Vinorelbine  (IV)  in  Children  with 
Refractory/Relapsed  Hodgkin  Disease 


52 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


Lieuw  KH 
#205014 

Lieuw  KH 
#201108 

Lieuw  KH 
#205069 

Lieuw  KH 
#200049 

Lieuw  KH 
#98090 

Lieuw  KH 
#201054 


Lieuw  KH 
#205105 

Lieuw  KH 
#94092 

Lieuw  KH 
#95058 

Lieuw  KH 
#96097 

Lieuw  KH 
#200018 

Lieuw  KH 
#200048 

Lieuw  KH 
#203105 

Maranich  AM 
#206045 

Moffitt  DR 
#204040 

Puntel  RA 
#204028 

Puntel  RA 
#203046 


0  C  COG  AHOD0321,  A  Phase  II  Study  of  Weekly  Gemcitabine  and 
Vinorelbine  in  Children  with  Recurrent  or  Refractory  Hodgkin 
Disease 

0  C  COG  ANBL00B1,  Neuroblastoma  Biology  Studies 

C  C  COG  ANHL0121,  A  Phase  II  Study  of  Rituximab  (IND#7028)  and 
Ifosfamide,  Carboplatin  and  Etoposide  (ICE)  Chemotherapy  in 
Children  with  Recurrent/Refractory  B-cell  (CD20+)  Non-Hodgkin 
Lymphoma  and  B-cell  Acute  Lymphoblastic  Leukemia 

O  C  COG  D9902,  A  COG  Soft  Tissue  Sarcoma  Diagnosis,  Biology  and 
Banking  Protocol 

O  C  COG  P9442:  National  Wilms  Tumor  Late  Effects  Study 

C  C  COG  P9934:  Systemic  Chemotherapy,  Second  Look  Surgery  and 

Conformal  Radiation  Therapy  Limited  to  the  Posterior  Fossa  and 
Primary  Site  for  Children  >  8  Months  and  <  3  Years  with  Non¬ 
metastatic  Medulloblastoma  -  A  Children's  Oncology  Group  Phase 
III  Study 

O  C  COG-LTF,  A  Groupwide  Process  for  Collecting  Long  Term  Follow 
Up  Data 

O  C  POG  9351/CCG  7921:  Trial  of  Doxorubicin,  Cisplatin,  and 

Methotrexate  With  and  Without  Ifosfamide,  With  and  Without 
Muramyl  Tripeptide  Phosphatidyl  Ethanolamine  (MTP-PE)  for 
Treatment  of  Osteogenic  Sarcoma 

C  C  POG  9400:  ALinC  16  Classification  (C)  Protocol 

O  C  POG  9440:  National  Wilms  Tumor  Study  -  5:  Therapeutic  Trial  and 
Biology  Study 

C  C  POG  P9761:  Phase  II  Trial  of  Irinotecan  in  Children  with  Refractory 
Solid  Tumors:  A  COG  Study 

O  C  POG  P9851:  Osteosarcoma  Biology  Protocol,  Companion  to  Group- 
Wide  Therapeutic  Studies 

C  C  POG  P9962  A  Phase  II  Study  of  Intrathecal  Topotecan  in  Patients 
with  Refractory  Meningeal  Malignancies 

C  L  The  Pontine  Valentine  Leucocidin  Virulence  Factor  in  Staph  Aureus 
Disease:  A  Retrospective  Study  Analyzing  CA-MRSA  Incidence  and 
Clinical  Severity 

O  M  National  Cystic  Fibrosis  Foundation  Patient  Data  Registry 

O  A  Pediatric  Intubation  Training  Utilizing  the  Ferret  (mustela  putorius 
furo)  Model 

O  M  Telemedicine  Based  Ultrasound  for  Detecting  Neonatal  Heart 

Disease  in  Babies  at  Remote  Military  or  Native  American  Health 
Care  Facilities 


DEPARTMENT  OF  PHARMACY 

Booth  HS  C  L  Assessment  of  LDL-Cholesterol  Goal  Attainment  Among  Patients  at 

#206092  a  Very  High  Risk  For  Secondary  Cardiovascular  Events  in  a 

Pharmacist-Managed  Lipid  Clinic 


53 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


DEPARTMENT  OF  PREVENTIVE  MEDICINE 


Hoang  HV 
#206056 

C 

L 

Will  Power:  Is  Personal  Motivation  Associated  with  Retention  in  the 
Army? 

Hughes  VR 
#206066 

C 

L 

Self  Identification  as  a  Predictor  of  Subsequent  Mental  Health 
Diagnosis 

Moores  CA 
#206074 

C 

L 

Military  Rank  as  a  Risk  Factor  for  Type  2  Diabetes  in  Military 
Spouses 

Ross  TW 
#206033 

C 

L 

Hazards  to  Hearing  and  Threshold  Shifts:  The  Results  of 
Deployment  to  a  Combat  Environment 

Wiesen  AR 
#205099 

O 

L 

CD4+  T  Cell  Epitope  Identification  for  Protective  Antigen  of  Bacillus 
Anthracis 

DEPARTMENT  OF  PSYCHIATRY 

Peterson  KA 
#204089 

O 

M 

A  Placebo- Controlled  Trial  of  Prazosin  vs.  Paroxetine  in  Combat 
Stress-Induced  Nightmares  and  Sleep  Disturbance 

Peterson  KA 
#206011 

O 

M 

Prazosin  for  the  Treatment  of  Trauma  Nightmares  in  PTSD 

DEPARTMENT  OF  PSYCHOLOGY 

Darnell  JN 
#206062 

O 

L 

Military  Readiness  Risks:  Leader  Perspectives  Impact  on  Mandatory 
Addiction  Referrals 

Johnson  PL 
#205019 

O 

L 

Theory-Guided  Anticipatory  Guidance 

Lucenko  BA 
#206088 

O 

L 

Exposure  to  Death  and  Dying  and  Mental  Health  Response  in 
Operation  Iraqi 

Reger  GM 
#206118 

O 

L 

User  Centered  Design  Feedback  for  the  Virtual  Iraq 

Reger  MA 
#206077 

O 

L 

Army  Suicide  Event  Report:  Data  Analysis 

DEPARTMENT  OF  RADIOLOGY 

Balingit  AG 
#202117 

O 

L 

Intravenous  Administration  of  131  I-6-B  Iodomethylnorcholesterol 
(NP-59)  for  Adrenal  Evaluation  and  Imaging 

Reece  WB 
#206053 

O 

M 

NSABP  B-39  /  RTOG  0413  A  Randomized  Phase  III  Study  of 
Conventional  Whole  Breast  Irradiation  (WBI)  Versus  Partial  Breast 
Irradiation  (PBI)  for  Women  with  Stage  0,  I  or  II  Breast  Cancer 

Reece  WB 
#204069 

O 

S 

SWOG  RTOG  0212,  A  Phase  II/III  Randomized  Trial  of  Two  Doses 
(Phase  Ill-Standard  vs.  High)  and  Two  High  Dose  Schedules  (Phase 
Il-Once  vs  Twice  Daily)  for  Delivering  Prophylactic  Cranial 
Irradiation  for  Patients  With  Limited  Disease  Small  Cell  Lung 
Cancer 

Semerad  DC 
#205134 

O 

L 

Clinical  Trial  and  Retrospective  Review  to  Determine  the  Sensitivity 
and  Specificity  of  Iminodiacetic  Acid  Scintigraphy  for  Fibrolamellar 
Carcinoma 

Statler  JD 
#205051 

O 

L 

Carotid  Stenosis:  Digital  Subtraction  Angiography,  Magnetic 
Resonance  Angiography,  and  the  Evolution  of  Preoperative 
Evaluation 

Statler  JD 
#205024 

O 

L 

Computed  Tomography  of  the  Abdomen  Following  Appendectomy 

54 


Prin.  Invest. 
#Protocol  No. 


S  T  Title 


SPECIAL  FORCES  GROUP,  FORT  LEWIS 


Wendt  EP 
#206106 

0 

A 

1st  Special  Forces  Group  (Airborne)  Combat  Trauma  Management 
Procedures  Training  for  Special  Forces  Medical  Personnel 

Wendt  EP 
#206018 

0 

A 

1st  Special  Forces  Group  (Airborne)  Instructing  Combat  Trauma 
Management  to  Trainees 

GENERAL  SURGERY  SERVICE,  DEPARTMENT  OF  SURGERY 

Arthurs  ZM 
#206032 

0 

L 

Colonic  Ischemia  Following  Abdominal  Aortic  Aneurysm  Repair- - 
Open  vs.  Endovascular  Approaches 

Arthurs  ZM 
#206123 

0 

L 

Renovascular  Hypertension:  A  Retrospective  Analysis  of  Renal 
Artery  Stenting  Outcomes 

Arthurs  ZM 
#203090 

0 

L 

The  Association  Of  Elevated  C-Reactive  Protein  With  Presence  And 
Degree  Of  Carotid  Stenosis 

Azarow  KS 
#203107 

C 

M 

A  Multicenter,  Open-Label,  Randomized  Study  To  Compare  The 
Safety  And  Efficacy  Of  Once  Daily  Levofloxacin  Along  With  Once 
Daily  Metronidazole  Versus  Piperacillin  /  Tazobactam  In  The 
Treatment  Of  Complicated  Appendicitis,  Protocol  CAPSS-151 

Azarow  KS 
#204013 

C 

L 

Abdominal  Wall  Defects:  Does  the  Intraabdominal  Pressure  Affect 
Outcome? 

Beekley  AC 
#204058 

0 

A 

Advanced/Combat  Trauma  Management  Training  Using  Animal 
Models  (Domestic  Goat/Capra  hircus,  Pig/Sus  scrofa) 

Beekley  AC 
#205075 

0 

L 

Operation  Iraqi  Freedom  Combat  Trauma  Database  from  the  31st 
Combat  Support  Hospital,  Baghdad,  Iraq 

Brown  TA 
#204106 

C 

M 

A  Multicenter,  Double-blind,  Randomized,  Phase  3  Study  to 

Compare  the  Safety  and  Efficacy  of  Intravenous  Doripenem  with 
that  of  Meropenem  in  Complicated  Intra-abdominal  Infections 

Brown  TA 
#206015 

0 

M 

A  Prospective  Randomized  Study  Comparing  Sentinel  Lymph  Node 
(SLN)  Evaluation  with  Standard  Pathological  Evaluation  for  the 
Staging  of  Colon  Carcinoma 

Brown  TA 
#205074 

C 

M 

A  Randomized,  Double-Blind  Study  of  GT267-004  Versus 
Vancomycin,  and  GT267-004  Versus  Metronidazole,  in  Patients  with 
C. Difficile-Associated  Diarrhea;  Protocol  GD3-170-301 

Brown  TA 
#205096 

C 

M 

ACOSOG  Z4031,  Use  of  Proteomic  Analysis  of  Serum  Samples  for 
Detection  of  Non- Small  Cell  Lung  Cancer 

Brown  TA 
#206101 

0 

M 

ACOSOG  Z6041:  A  Phase  II  Trial  of  Neoadjuvant  Chemoradiation 
and  Local  Excision  for  uT2uN0  Rectal  Cancer 

Brown  TA 
#205098 

T 

M 

ACOSOG  Z9031,  A  Phase  III  Randomized  Study  of  Preoperative 
Radiation  Plus  Surgery  Versus  Surgery  Alone  for  Patients  with 
Retroperitoneal  Sarcomas  (RPS) 

Brown  TA 
#205097 

T 

M 

Biological  Relevance  of  Sentinel  Lymph  Node  (SLN) 

Micrometastasis  in  Patients  With  Colon  Carcinoma 

Brown  TA 
#203077 

E 

A 

Comparative  Medical/Surgical  Research  and  Development  (Limited) 

Brown  TA 
#206110 

0 

A 

Comparative  Medical/Surgical  Research  and  Development  (Limited) 

Brown  TA 
#205112 

0 

S 

RTOG  0412  /  SWOG  S0332,  Phase  III  Randomized  Trial  of 
Preoperative  Chemotherapy  Versus  Preoperative  Concurrent 
Chemotherapy  and  Thoracic  Radiotherapy  Followed  By  Surgical 
Resection  and  Consolidation  Chemotherapy  in  Favorable  Prognosis 
Patients  with  Stage  IIIA  (N2)  Non-Small  Cell  Lung  Cancer 

55 


Prin.  Invest. 
#Protocol  No. 

Brown  TA 
#205113 

Brown  TA 
#205114 

Carter  PL 
#202013 

Cronk  DR 
#204001 

Cronk  DR 
#206040 

Cuadrado  DG 
#206041 

Cuadrado  DG 
#203114 

Cuadrado  DG 
#206016 

Cuadrado  DG 
#203034 

Eckert  MJ 
#206047 

Eckert  MJ 
#206115 

Eckert  MJ 
#205080 

Eggebroten  WE 
#204101 

Hartenstine  MJ 
#204100 

Herbert  GS 
#206026 

Herbert  GS 
#206010 


Herbert  GS 
#201020 

Herbert  GS 
#206027 

Herbert  GS 
#205125 


Herbert  GS 
#205126 

Herbert  GS 
#205063 

Husain  FA 
#202073 


S  T  Title 

C  S  SWOG  9430,  A  Phase  II  Trial  of  Complete  Surgical  Resection  for 

Stage  IV  Melanoma  -  Surgical  Resection  With  Biological  Evaluation 
And  Clinical  Follow-Up 

C  S  SWOG  9431,  Cytogenetic  Molecular  and  Cellular  Biology  Studies  in 
Metastatic  Melanoma  Patients,  Ancillary 

O  L  Bariatric  Surgery  Effects  on  the  Comorbidities  of  Obesity 

O  L  Does  Intestinal  Fatty  Acid  Binding  Protein  Predict  Strangulation  in 
Mechanical  Small  Bowel  Obstruction? 

O  L  Does  SDF-1  Production  by  Atherosclerotic  Plaques  Correlate  with 
Severity  of  Carotid  Artery  Stenosis? 

O  L  Breast  Abscesses  Following  Nipple  Piercing:  A  Case  Series  and 
Review  of  the  Literature 

C  L  Chewing  Gum  for  the  Reduction  of  Postoperative  Ileus  After 
Elective  Open  Colectomy 

T  L  Determining  the  Incidence  of  Sonographically  Detectable  Wound 
Seromas  in  the  Morbidly  Obese:  A  Pilot  Study 

O  L  Impact  of  Gastric  Bypass  with  Subtotal  Gastrectomy  on  Plasma 
Ghrelin  Profile 

C  L  Bronchoscopy  in  the  Blast  Injury  Patient 

O  A  Hypoxemic  Reperfusion  Following  Lower  Torso  Ischemia  in  sp.  Sus 
scrofa 

O  A  Stem  cell  engraftment  in  the  lipopolysaccharide  mouse  (Mus 
musculus)  model  of  acute  inflammatory  injury 

T  A  Advanced  Trauma  Life  Support  (ATLS)  Training  Utilizing  the  Goat 
(Capra  hircus) 

O  L  Human  Blood  Collection  for  Bench  Research  Initiatives 

O  L  Determination  of  Telomerase  Activity  in  Atypical  Ductal 
Hyperplasia  of  the  Breast 

O  L  Does  Control  of  Inflammation  Prior  to  Intervention  for  Carotid 
Artery  Disease  or  Lower  Extremity  Peripheral  Arterial  Disease 
Affect  Outcome? 

O  L  Learning  Curves  for  Airway  Assessment  and  Endotracheal 
Intubation  -  Cumulative  Sum  Analysis 

O  L  Prognostic  Significance  of  Telomerase  Activity  in  T1  and  T2  Rectal 
Adenocarcinoma  for  Patients  Undergoing  Transanal  Excision 

O  L  Prospective,  Randomized,  Placebo- Controlled  Trial  of  Tegaserod  for 
Treatment  of  Delayed  Gastric  Emptying  after 
Pancreaticoduodenectomy 

O  L  Prospective,  Randomized,  Placebo- Controlled  Trial  of  Tegaserod  for 
Treatment  of  Post-Operative  Ileus  Following  Partial  Colectomy 

O  L  The  Impact  of  Nodal  Micrometastases  on  Survival  of  Women  with 
Breast  Cancer 

T  M  Ultrasound  Imaging  for  Central  Venous  Catheter  Placement  in  the 
Intensive  Care  Unit:  Is  Real-time  Really  Better?  A  Prospective 
Randomized  Trial 


56 


Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Kjorstad  RJ 
#206043 

O 

L 

Colorectal  Complications  of  External  Beam  Radiation  vs. 
Brachytherapy  for  Prostate  Cancer 

Kjorstad  RJ 
#205127 

T 

L 

Screening  for  Occult  Vascular  Injuries  Utilizing  a  Portable 

Ultrasound  Unit 

Martin  MJ 
#206079 

O 

L 

The  Utility  and  Impact  of  Standard  Trauma  Triage  Criteria  in  the 
Elderly 

Mullenix  PS 
#203091 

T 

L 

Prospective  Evaluation  Of  Intraoperative  Duplex  Ultrasound  As  An 
Adjunct  To  Technical  Excellence  During  Carotid  Endarterectomy 

Perry  JT 
#206061 

O 

L 

Utilization  of  Genetic  Testing  and  Counseling  Among  Patients  with 
Hereditary  Non-Polyposis  Colorectal  Cancer 

Perry  JT 
#206038 

O 

L 

Venous  Distensibility  Index  as  a  Predictor  of  Radiocephalic 
Arteriovenous  Fistula  Maturation 

Sohn  VY 
#206116 

O 

L 

Breast  Papillomas  in  the  Era  of  Stereotactic  Core  Biopsy 

Sohn  VY 
#206114 

O 

L 

Institutional  Accuracy  of  11-  and  8-  Gauge  Vacuum-Assisted  Core 
Biopsy  of  Mammographic  Breast  Lesions 

Sohn  VY 
#206004 

O 

A 

The  Evaluation  of  Telomerase  Inhibition  in  a  Colorectal  Metastasis 
Model  Using  Nude  Mice  (Mus  musculus) 

OPHTHALMOLOGY  SERVICE,  DEPARTMENT  OF  SURGERY 

Ainbinder  DJ 
#204085 

C 

L 

Flow  Cytometry  Descriptive  Findings  from  Lacrimal  Sac  Biopsy 
Specimens,  Obtained  in  Standard  Dacryocystorhinostomy 

Boden  JH 
#206076 

C 

L 

Methicillin  Resistant  Ascending  Facial  and  Orbital  Cellulitis  in 
Operation  Iraqi  Freedom  Troop  Population 

Boden  JH 
#206124 

O 

L 

The  use  of  lidocaine  gel  prior  to  povidone  -  iodine  antisepsis  and  its 
effect  on  microbial  survivability 

Solverson  DJ 
#206006 

O 

L 

Virtual  Ophthalmosurgical  Simulator  as  a  Valid  Training  Tool 

Torres  MF 
#204049 

C 

L 

Long-Term  Follow-up  of  Military  Personnel  Following 

Photorefractive  Keratectomy  With  Mitomycin- C 

Torres  MF 
#205083 

O 

L 

Ophthalmic  Phentolamine  Multiple  Dose  Clinical  Trial 

ORTHOPEDICS  SERVICE,  DEPARTMENT  OF  SURGERY 

Antosh  IJ 
#206022 

O 

L 

Accuracy  of  Reduction  Utilizing  Volar  Fixation  for  Dorsally 

Displaced  Fractures  of  the  Distal  Radius 

Arrington  ED 
#206037 

O 

L 

A  Retrospective  Review  of  Injuries  Sustained  During  Operation  Iraq 
Freedom  and  Operation  Enduring  Freedom  Requiring  Medical 
Evacuation  to  a  Tertiary  Medical  Center 

Arrington  ED 
#201015 

O 

B 

Biomechanics  of  Various  Coracoclavicular  Ligament  Reconstruction 
Techniques 

Arrington  ED 
#204051 

O 

L 

Efficacy  of  Post-operative  Hip  Spica  Wrap  Dressing  after  Primary 

Hip  Arthroplasty  in  Preventing  Post-operative  Wound 

Complications  and  Blood  Transfusions 

Arrington  ED 
#203036 

O 

L 

Intramedullary  Fixation  of  Displaced  Acute  Middle  One-Third 

Clavicle  Fractures 

Arrington  ED 
#206085 

O 

L 

Pectoralis  Major  Repairs  in  Active  Duty  Soldiers 

Arrington  ED 
#206036 

O 

L 

Return  to  Full  Duty  after  Anterior  Cruciate  Ligament 

Reconstruction  in  the  Military  Population 

57 

Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Arrington  ED 
#200065 

c 

M 

Study  of  the  Treatment  of  Articular  Repair  (STAR):  A  Prospective, 
Longitudinal  Within  Patient  Evaluation  of  the  Effectiveness 
(Durability)  of  Carticel  (autologous  cultured  chondrocytes) 

Compared  to  Non-Carticel  Surgical  Treatment  for  Articular 

Cartilage  Defects  of  the  Knee 

Arrington  ED 
#200125 

O 

L 

Subacromial  Injection  of  Corticosteroids  versus  Ketoralac  for 
Treatment  of  Shoulder  Impingement  Syndrome 

Benfanti  PL 
#205300 

O 

M 

Stryker  Biotech-  OP-1  Bone  Morphogenetic  Protein,  BMP-7  (HUD) 

DeVine  JG 
#205053 

O 

M 

A  Prospective,  Randomized  Clinical  Investigation  of  the  Cervitech, 
Inc.  Porous  Coated  Motion  Artificial  Disc  for  Stabilization  of  the 
Cervical  Spine  at  One  Level  between  C3-C4  and  C7-T1 

DeVine  JG 
#206120 

O 

M 

A  Single  Blind,  Multi- Center,  Randomized,  Prospective  Clinical 
Study  Comparing  Optecure™  Autograft  Extender  to  Autograft  Only 
in  Fusion  of  the  Lumbar  Spine 

DeVine  JG 
#206081 

O 

L 

Magnetic  resonance  imaging  evaluation  of  adjacent  segments  after 
lumbar  disc  arthroplasty  using  the  SB  Charite  implant 

Devine  JG 
#206082 

O 

L 

Magnetic  Resonance  Imaging  Evaluation  of  Adjacent  Segments 

After  Cervical  Disc  Arthroplasty  Using  the  PCM  Implant 

Driver  VR 
#205054 

c 

M 

A  Phase  2,  Double-Blind,  Randomized,  Placebo- Controlled,  Dose- 
Ranging  Study  to  Evaluate  the  Efficacy  and  Safety  of  Three  Doses  of 
TAK-128  in  Subjects  with  Mild  to  Moderate  Diabetic  Peripheral 
Neuropathy 

Driver  VR 
#204098 

T 

L 

Cost  of  Treating  Diabetic  Foot  Ulcers  -  At  Madigan  Army  Medical 
Center 

Ghidella  SD 
#205013 

O 

M 

A  Double-blind,  Randomized,  Placebo-controlled  Phase  2b  Study  to 
Establish  the  Effective  Dose  Range  and  to  Evaluate  the  Safety  of 
Chrysalin  in  Adult  Subjects  with  a  Fractured  Distal  Radius 

Ghidella  SD 
#206009 

O 

L 

A  Randomized  Study  of  Volar  Fixed-Angle  Plate  Fixation  Versus 
Closed  Management  for  Fractures  of  the  Distal  Radius 

Ghidella  SD 
#205079 

O 

A 

Microsurgery  Training  Utilizing  The  Rat  (rattus  norvegieus)  as  a 
Teaching  Model 

Herzog  JP 
#201112 

c 

L 

Post-operative  Shoulder  Pain:  A  Prospective  Randomized  Trial 
Comparing  the  Pain  Infusion  Pump  to  the  Pre-induction 

Interscalene  Block 

Schweinberger  MH 
#202091 

T 

L 

A  Prospective,  Randomized,  Stratified,  Parallel  Group,  Comparison 
Study  of  the  Healing  Rate  of  Chronic  Neuropathic  Ulcers  Treated 
with  Hyalofill  versus  Regranex 

OTOLARYNGOLOGY  SERVICE,  DEPARTMENT  OF  SURGERY 

Baumgartner  BJ 
#204009 

c 

L 

Evaluation  of  Dizziness  /  Vertigo  by  MRI/MRA:  A  Clinical  Outcomes 
Study 

Crawford  JV 
#205052 

O 

M 

MET™  Fully  Implantable  Ossicular  Stimulator  Clinical  Trial 
Protocol 

Crawford  JV 
#204042 

T 

M 

Rapid  Employment  of  Acetylcysteine  Treatment  for  Otologic 
Recovery  (REACTOR),  A  Prospective,  Multicenter,  Randomized, 
Double-blind,  Parallel,  Placebo-controlled  Study  Assessing  the 
Efficacy  of  the  Nutritional  Supplement  N- Acetylcysteine  Treatment 
of  Acute  Acoustic  Trauma 

58 


Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Demars  SM 
#206058 

c 

L 

Effect  of  Smoking  on  Rate  of  Post-tonsillectomy  Hemorrhage 

Demars  SM 
#206044 

c 

L 

Review  of  Postoperative  Complications  after  BAHA  Implantation  at 
Madigan  AMC  and  Virginia  Mason  MC 

Grafenberg  MR 
#205050 

O 

L 

Celecoxib  Versus  Oxycodone  in  Uvulopalatopharyngoplasty  Surgery: 
A  Comparison  of  Post-Operative  Risks  and  Benefits 

Grafenberg  MR 
#205120 

O 

L 

Complications  and  Audiologic/Tympanometric  Findings  in  Children 
with  Cleft  Lip/Palate  and  Cleft  Palate 

Poss  JM 
#206125 

O 

L 

Base  of  Tongue  Reduction  for  Persistent  Obstructive  Sleep  Apnea 
Using  the  Coblator  II  System:  A  Pilot  Study 

Poss  JM 
#206020 

O 

L 

Clinical  Survey  of  Community  Physicians:  Post-Tympanostomy 

Tube  Placement  and  Swimming  Precautions/Treatment  Otitis  Media 
with  Effusion 

Sorensen  DM 
#203016 

E 

A 

Pediatric  Bronchoesophagology  Laboratory  Using  Swine  (Sus  scrofa) 

Sorensen  DM 
#206030 

O 

A 

Pediatric  Bronchoesophagology  Laboratory  using  Swine  (Sus  scrofa) 

Sorensen  DM 
#204070 

O 

L 

Perioperative  Immunonutrition  in  Head  and  Neck  Cancer 

Spear  SA 
#206057 

O 

L 

Review  of  Thyroid  Cancer  Treatment  Outcomes  at  a  Major  Medical 
Center  from  1996-2000 

Thomas  RF 
#205009 

O 

L 

Inferior  Turbinate  Reduction  Comparing  Turbinate  Microdebrider, 
Coblation  and  Bipolar  Cautery 

UROLOGY  SERVICE,  DEPARTMENT  OF  SURGERY 

Baker  KC 
#205129 

T 

M 

A  Multi-Center,  Open-Label  Evaluation  of  the  Safety  of  Silodosin  in 
the  Treatment  of  the  Signs  and  Symptoms  of  Benign  Prostatic 
Hyperplasia,  Protocol  #SI040011 

Baker  KC 
#205092 

O 

M 

A  Multi-center,  Randomized  Clinical  Investigation  of  TrelstarTM 
Versus  Continued  Therapy  in  Patients  Receiving  Lupron  or  Zoladex 
for  Advanced  Prostate  Cancer 

Baker  KC 
#205072 

c 

M 

A  Multi-Center,  Randomized,  Double-Blind,  Placebo  Controlled, 
Parallel  Evaluation  of  the  Efficacy  and  Safety  of  Silodosin  in  the 
Treatment  of  the  Signs  and  Symptoms  of  Benign  Prostatic 
Hyperplasia,  Protocol  #  SI04009 

Baker  KC 
#203035 

O 

M 

A  Multi-Institutional  Pilot  Study  to  Evaluate  Molecular  Markers  in 
Urine  and  Serum  in  the  Early  Detection  of  Prostate  Cancer 

Baker  KC 
#201113 

O 

M 

A  Phase  III,  Extension  Study  to  Evaluate  the  Safety  of  10  mg 
Atrasentan  in  Men  with  Hormone-Refractory  Prostate  Cancer  (MOO- 
258) 

Baker  KC 
#201107 

O 

M 

A  Phase  III,  Randomized,  Double-Blind,  Placebo- Controlled  Study  of 
the  Safety  and  Efficacy  of  10  mg  Atrasentan  in  Men  with  Metastatic, 
Hormone-Refractory  Prostate  Cancer  (MOO-211) 

Baker  KC 
#201121 

O 

M 

A  Phase  III,  Randomized,  Double-Blind,  Placebo-Controlled  Study  of 
the  Safety  and  Efficacy  of  10  mg  Atrasentan  in  Men  with  Non- 
Metastatic,  Hormone-Refractory  Prostate  Cancer  (MOO-244) 

Baker  KC 
#204005 

O 

M 

A  Phase  III,  Randomized,  Double-Blind,  Placebo- Controlled  Trial 
Evaluating  the  Ability  of  Risedronate  to  Prevent  Skeletal  Related 
Events  in  Patients  with  Metastatic  Prostate  Cancer  Commencing 
Hormonal  Therapy,  Protocol  #GU02-41 

59 


Prin.  Invest. 
#Protocol  No. 


Baker  KC 
#204122 


Baker  KC 
#206100 


Baker  KC 
#206072 


Baker  KC 
#205006 


Baker  KC 
#204091 


Baker  KC 
#204025 

Baker  KC 
#205119 

Baker  KC 
#205017 

Baker  KC 
#204121 


Baker  KC 
#206039 

Baker  KC 
#204120 

Baker  KC 
#205040 

Baker  KC 
#204079 


DeCastro  BJ 
#202065 

DeCastro  BJ 
#205136 

Nelson  DM 
#205076 


O'Reilly  KJ 
#203053 


S  T  Title 

CM  A  Randomized,  Double  Blind,  Placebo  Controlled,  Four  Arm 

(Placebo,  Tolterodine  ER,  Tamsulosin,  and  Tolterodine  ER  plus 
Tamsulosin)  Study  to  Evaluate  the  Clinical  Efficacy  and  Safety  of 
Tolterodine  ER  4  mg  in  Men  who  have  Frequency  and  Urgency,  with 
or  without  Urinary  Urge  Incontinence,  with  or  without  Bladder 
Outlet  Obstruction,  Protocol  Number  A6121120 

O  M  A  Randomized,  Double-Blind,  Multicenter  Study  of  Denosumab 

Compared  with  Zoledronic  Acid  (Zometa®)  in  the  Treatment  of  Bone 
Metastases  in  Men  with  Hormone-Refractory  Prostate  Cancer 
(20050103) 

O  M  A  Randomized,  Double-Blind,  Placebo- Controlled,  Multi-Center 

Phase  3  Study  of  Denosumab  on  Prolonging  Bone  Metastasis-Free 
Survival  in  Men  with  Hormone-Refractory  Prostate  Cancer 

O  M  A  Randomized,  Double-Blind,  Placebo- Controlled,  Multicenter 

Efficacy  and  Safety  Study  of  Toremifene  Citrate  for  the  Prevention 
of  Bone  Fractures  in  Men  with  Prostate  Cancer  on  Androgen 
Deprivation  Therapy  (Protocol  #G300203) 

O  M  A  Randomized,  Double-Blind,  Placebo- Controlled  Study  to  Evaluate 
AMG  162  in  the  Treatment  of  Bone  Loss  in  Subjects  Undergoing 
Androgen-Deprivation  Therapy  for  Non-Metastatic  Prostate  Cancer 

C  M  An  Evaluation  of  Semen  Characteristics  after  40  Weeks  Daily 
Dosing  with  20  mg  Tadalafil 

O  L  Expression  of  CXCR4  in  Archived  Prostate  Cancer  Specimens  and 
its  Association  with  Patient  Demographics,  Pathologic  Results,  and 
Outcomes 

O  A  Madigan  Army  Medical  Center  Advanced  Laparoscopic  Training 
Using  the  Pig  (Sus  scrofa) 

T  L  Prevalence  of  PCR  Detectable  Human  Papillomavirus  (HPV)  in 
Sexually  Active  Males  -  A  Comparison  of  Specimen  Collection 
Methods  and  Genitourinary  Sites 

O  M  SEER  Rapid  Response  Surveillance  Study  #5,  Prostate  Cancer 
Therapy  Selection  (PCATS)  Study 

O  L  The  Effect  of  Flexible  Cystoscopy  on  the  Serum  PSA  Values 

O  L  The  Epidemiology  of  Nephrolithiasis  in  Soldiers  Returning  From 

Operation  Iraqi  Freedom 

O  M  Uniformed  Services  University  National  Prostate  Cancer  Database 
for  the  Center  for  Prostate  Disease  Research  (CPDR)  with  Patterns 
of  Care,  Outcomes,  and  Prognostic  Analyses,  Protocol  Number 
GT90CM 

O  M  Oral  Ketoconazole  For  Prevention  Of  Postoperative  Penile  Erection, 
A  Prospective,  Randomized,  Double  Blind  Trial 

O  L  The  Incidence  of  Infection  and  Stent  Colonization  in  Patients  With 
and  Without  Strings 

O  L  Madigan  Army  Medical  Center's  Current  Clinical  Practice  and 

Experience  With  Osteopenia  And  Fractures  In  Men  Treated  With 
Androgen  Deprivation  Therapy 

CM  A  Clinical  Trial  Evaluating  the  Safety  and  Efficacy  of  ABX-EGF  in 
Patients  with  Hormone  Resistant  Prostate  Cancer  Elevated  PSA 
With  or  Without  Metastasis,  Protocol  Number  ABX-0310 


60 


Prin.  Invest. 
#Protocol  No. 

O’Reilly  KJ 
#205033 


O’Reilly  KJ 
#206024 


O’Reilly  KJ 
#204116 


Peterson  AC 
#205073 


Peterson  AC 
#205086 


Peterson  AC 
#205116 


Peterson  AC 
#205027 


Peterson  AC 
#203042 


Peterson  AC 
#205135 

Peterson  AC 
#206031 

Peterson  AC 
#206117 


Peterson  AC 
#202122 

Peterson  AC 
#204078 


S  T  Title 

CM  A  Phase  2,  8-Week,  Multi-Center,  Randomized,  Double-Blind, 

Placebo- Controlled,  Parallel  Group  Study  Evaluating  the  Efficacy, 
Tolerability  and  Safety  of  [S,S]-Reboxetine  (PNU-165442G)  for 
Stress  Urinary  Incontinence  in  Women,  Protocol  A6061023 

T  M  A  Twelve-Week  Randomized,  Double-Blind,  Placebo- Controlled, 

Parallel  Group,  Forced  Titration,  Proof  of  Concept  Study  to  Assess 
the  Efficacy,  Safety  and  Tolerability  as  well  as  the  Pharmacokinetic 
Profile  of  60  mg  and  120  mg  of  GW679769  (GW679769) 
administered  once  daily  vs.  Placebo  in  Women  with  Overactive 
Bladder 

C  M  Phase  2,  Multi-Center,  Randomized,  Double-blind,  Placebo- 

Controlled,  3  Arm,  12-Month  Study  to  Evaluate  the  Effects  of  GPI 
1485  on  Erectile  Function  in  Patients  Undergoing  Bilateral  Nerve- 
Sparing  Radical  Retropubic  Prostatectomy  for  Prostatic  Carcinoma, 
Protocol  Number  0501-0202 

O  M  A  Phase  2,  Randomized,  Multicenter,  Placebo- Controlled,  Double- 
Blind  Dose-Ranging  Clinical  Trial  to  Study  the  Efficacy  and  Safety 
of  5,  15,  or  25  mg/day  of  CyPat™  (Cyproterone  Acetate)  for  the 
Treatment  of  Hot  Flashes  following  Surgical  or  Medical  Castration 
of  Prostate  Cancer  Patients,  Protocol  #DR-PCA-201 

CM  A  Randomized,  Double  Blind,  Placebo  and  Active-Controlled  Efficacy 
and  Safety  Study  of  SSR240600C,  in  Patients  with  Overactive 
Bladder  or  Urge  Urinary  Incontinence,  Protocol  #  ACT  5190 

T  M  A  Randomized,  Double-Blind,  Parallel-Design,  Placebo  Controlled 
Study  to  Evaluate  the  Effects  of  5  mg  Tadalafil  (IC351,  LY450190) 
and  50  mg  Sildenafil  Administered  Once  Daily  for  6  Months  on 
Visual  Function  in  Healthy  Subjects  or  Subjects  with  Mild  Erectile 
Dysfunction,  Protocol  H6D-MC-LVGO 

O  M  A  Randomized,  Double-Blind,  Placebo- Controlled,  Multicenter 

Efficacy  and  Safety  Study  of  Toremifene  Citrate  for  the  Prevention 
of  Prostate  Cancer  in  Men  with  High  Grade  Prostatic  Intraepithelial 
Neoplasia  (PIN) 

O  M  A  Randomized,  Double-Blind,  Placebo- Controlled,  Parallel  Group 

Study  of  the  Efficacy  and  Safety  of  Dutasteride  0.5  mg  Administered 
Orally  Once  Daily  for  Four  Years  to  Reduce  the  Risk  of  Biopsy- 
Detectable  Prostate  Cancer,  Protocol  Number  ARI40006 

O  L  Acute  Urinary  Retention  and  the  Role  of  Fill  and  Pull  Voiding  Trials 

O  L  Adult  Circumcision:  Template  vs  Standard  Sleeve  Technique 

O  L  Comparison  of  Non-Contrast  Abdominal  Computed  Tomography 
(CT)  to  Contrast  CT,  Intravenous  Pyelography  (IVP)  and  Nuclear 
Renal  Scan  for  Determination  of  Renal  Function:  A  Retrospective 
Review 

O  L  Followup  of  Testicular  Microlithiasis  in  an  Asymptomatic 
Population 

O  M  Long-Term  Open-Label  Extension  Trial  for  Subjects  Completing  the 
Phase  3  Trial  of  Fesoterodine  (SP584)  for  the  Treatment  of 
Overactive  Bladder  Syndrome 


61 


Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Peterson  AC 
#206102 

O 

M 

Phase  II,  multicentre,  randomised,  double-blind,  placebo-controlled, 
pilot  study  to  determine  proof  of  efficacy,  safety,  tolerability  and 
pharmacokinetics  of  intravesical  PSD597  in  the  symptomatic 
management  of  interstitial  cystitis/painful  bladder  syndrome 
(I  C/PBS) 

Peterson  AC 
#204032 

0 

M 

Prospective,  Observational  Registry  and  Patient  Survey  of  the 
Management  of  Men  with  Symptomatic  Benign  Prostatic 

Hyperplasia  (BPH):  BPH  Registry  and  Patient  Survey  Protocol 
#L8890 

Peterson  AC 
#204086 

0 

M 

Prospective,  Open-Label,  Non-Comparative,  Multi-Center  Study  to 
Evaluate  the  Efficacy  and  Safety  of  Ciprofloxacin  Extended-Release 
(Cipro-XR)  1000  mg  Tablets  Given  Once  Daily  for  7  to  14  Days  in  the 
Treatment  of  Patients  18  Years  or  Older  with  Complicated  Urinary 
Tract  Infections  Caused  by  Pseudomonas  Aeruginosa  and  Other 
Common  Uropathogens 

Peterson  AC 
#203081 

0 

M 

Study  of  the  Safety  and  Effectiveness  of  the  Mentor  Two-Piece 
Inflatable  Penile  Prosthesis,  Protocol  Number  U108-802-4 

Pugliese  JM 
#205088 

0 

L 

The  Value  of  Resistive  Index:  A  Longitudinal  Study  of  Confounding 
Variables  and  Their  Impact  -  A  Pilot  Study 

VASCULAR  SURGERY,  DEPARTMENT  OF  SURGERY 

Andersen  CA 
#206012 

0 

M 

A  Comparative  Prospective,  Randomized,  Double-Masked,  Parallel 
Group,  Sham- Controlled  Trial  of  MIST  Therapy  for  the  Reduction  of 
Pain  in  Chronic  Lower  Extremity  Ulcers 

Andersen  CA 
#203079 

c 

M 

A  Double-Blind,  Randomized,  Parallel  Group,  Placebo- Controlled 
Study  to  Evaluate  the  Safety  and  Efficacy  of  NM-702  in  Subjects 
with  Intermittent  Claudication,  Protocol  Number  NCI-IC-0201 

Andersen  CA 
#206094 

0 

M 

A  Multi-Center,  Double-Blind,  Randomized,  Parallel,  Vehicle-and 
Standard  Care-Controlled,  Dose-Ranging  Study  Assessing  the 

Safety  and  Efficacy  of  MRE0094  Gel  When  Applied  Topically  for  90 
Days  to  Subjects  with  Diabetic,  Neuropathic,  Foot  Ulcers 

Andersen  CA 
#205111 

T 

M 

A  Phase  3,  Randomized,  Double-Blind,  Multinational  Trial  of 
Intravenous  Telavancin  Versus  Vancomycin  for  Treatment  of 
Complicated  Gram  Positive  Skin  and  Skin  Structure  Infections  with 
a  Focus  on  Patients  with  Infections  Due  to  Methicillin-resistant 
Staphylococcus  aureus  0018 

Andersen  CA 
#200088 

C 

L 

A  Prospective,  Randomized  Study  Comparing  the  Outcome  of 

Carotid  Endarterectomy  Using  New  Generation  Dacron  or 

Expanded  Polytetrafluoroethylene  (e-PTFE)  Carotid  Patching 

Andersen  CA 
#202086 

O 

M 

A  Randomized,  Controlled  Multicenter  Trial  of  Vacuum  Assisted 
Closure  Therapy™  in  the  Treatment  and  Blinded  Evaluation  of 
Diabetic  Foot  Ulcers  (Protocol  VAC2001-08) 

Andersen  CA 
#202115 

c 

M 

A  Randomized,  Controlled  Multicenter  Trial  of  Vacuum  Assisted 
Closure  Therapy™  in  the  Treatment  and  Blinded  Evaluation  of 
Amputation  Wounds  of  the  Diabetic  Foot,  Protocol  No.  VAC2001-07 

Andersen  CA 
#203055 

0 

M 

A  Randomized,  Controlled,  Multicenter  Trial  of  Vacuum  Assisted 
Closure  Therapy™  in  the  Treatment  and  Blinded  Evaluation  of 
Pressure  Ulcers,  Protocol  Number  VAC2001-01 

Andersen  CA 
#205010 

0 

M 

Linezolid  In  The  Treatment  Of  Subjects  With  Complicated  Skin  And 
Soft  Tissue  Infections  Proven  To  Be  Due  To  Methicillin-Resistant 
Staphylococcus  Aureus 

62 


Prin.  Invest. 
#Protocol  No. 

S 

T 

Title 

Andersen  CA 
#206071 

O 

M 

Phase  3,  Multicenter,  Multi-National,  Randomized,  Double-Blind, 
Placebo  Controlled  Study  to  Evaluate  the  Efficacy  and  Safety  of 
Alfimeprase  in  Subjects  with  Acute  Peripheral  Artery  Occlusion 
(NAPA- 3) 

Andersen  CA 
#205091 

0 

L 

The  Prevalence  and  Progression  of  Carotid  Artery  Stenosis  in 
Patients  Undergoing  Radiation  for  Head  and  Neck  Cancer 

Andersen  CA 
#203017 

c 

L 

The  Prevalence  of  Three  Major  Stroke  Risk  Factors  in  an  Enrolled 
Medicare  Population 

Roukis  TS 
#206127 

0 

M 

A  phase  2B  long-term,  randomized,  open-label,  safety  and 
tolerability  trial  comparing  [S,S]-Reboxetine  (PNU-165442G)  with 
routine  care  in  patients  with  chronic  painful  diabetic  peripheral 
neuropathy  (DPN)  Study  Number  A6061031 

Roukis  TS 
#206111 

0 

M 

Pivotal  Study  to  Evaluate  the  Efficacy  and  Safety  of  Dermal  -  Living 
Skin  Replacement  (Dermal  -  LSR)  in  the  Treatment  of  Chronic 
Diabetic  Foot  Ulcers 

Starnes  BW 
#206070 

0 

M 

A  Two-Part,  Multicenter,  Randomized,  Double-Blind,  Placebo- 
Controlled,  Study  to  Evaluate  the  Effect  of  Simvastatin,  Losartan, 

and  Pioglitazone  on  Cardiovascular  Disease  Biomarkers  in  Lower 
Extremity  Atherosclerotic  Plaque  Excised  from  Patients  with 
Peripheral  Arterial  Disease 


WEED  ARMY  COMMUNITY  HOSPITAL 

Wheeler  GA  CM  A  Phase  2  Study  to  Evaluate  the  Reactivity  and  Tolerability  of 

#205049  Intradermally  Administered  Doses  of  Coccidioidin  in  Human 

Subjects  in  a  Target  Population 


63 


Detail  Summary  Sheets 

Department  of  Anesthesia  &  Operative 

Services 


64 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206121 

Status:  Ongoing 

Title:  Comparison  of  Direct  Versus  Indirect  Laryngeal  Views  using  the  Video  Laryngoscope 
During  Standard  Intubation  Procedures 

Principal  Investigator:  LTC  Joseph  P.  Miller,  MC 

Department:  Anesthesia  &  Operative  Services 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion:  Funding: 

8/30/2006  -  Aug  2006  DCI 

Periodic  Review: 

N/A 

Study  Objective:  The  objectives  of  this  study  are  to  determine  whether  or  not  the  indirect 
laryngeal  view  offered  by  the  video  laryngoscope  is  superior  to  view  seen  by  direct  laryngoscopy, 
the  video  laryngoscope  offers  improved  anatomical  views  to  the  student  during  intubation  training 
and  the  video  laryngoscope  offers  improved  means  of  providing  external  laryngeal  manipulations 
to  facilitate  intubation. 

Technical  Approach:  All  patients  intubated  with  the  video  laryngoscope  will  be  entered  into  this 
study.  The  data  collection  sheet  will  be  completed  at  the  conclusion  of  intubation  by  the 
practitioner.  No  additional  testing,  or  any  medical  interventions  or  practice  outside  the  normal 
operating  procedure  will  be  employed.  The  only  difference  in  patient  care  with  participants  in  this 
study  versus  the  currently  employed  airway  management  with  the  video  laryngoscope,  will  be  that 
the  intubator  will  complete  a  questionnaire  at  the  conclusion  of  the  intubation  process.  No 
identifiers  of  the  patient  or  practitioner  will  be  on  the  questionnaire. 

Progress:  This  minimal  risk  protocol  received  initial  approval  by  the  Expedited  Review 
Committee,  effective  30  August  2006. 


65 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204010 

Status:  Completed 

Title:  Evaluation  of  the  Combat  Medic  Skills  Validation  Test 

Principal  Investigator:  LTC  Joseph  P.  Miller,  MC 

Department:  Anesthesia  &  Operative  Services 

Facility:  MAMC 

Associate  Investigator(s):  COL  (Ret)  Eileen  A.  Hemman,  PhD; 
COL  H.  Quigg  Davis,  USA 

COL  David  Gillingham,  MC; 

Start  -  Completion:  Funding:  Periodic  Review: 

1/13/2004  -  Jul  2005  Triservice  Nursing  Research  Program  via  The  10/14/2005 

Geneva  Foundation 

Study  Objective:  (1)  Operationalize,  standardize,  and  centralize  the  combat  medics'  validation 
testing  as  outlined  in  the  TC  (Training  Circular)  8-800  using  the  collaboration  of  the  joint  medical 
training  center  and  the  simulation  center.  (2)  Evaluate  the  psychometric  properties  of  the  SACMS- 
VT.  (3)  Test  a  random  sample  of  battlefield  medics  (91W)  to  assess  their  combat  medical  readiness 
skills  using  the  SACMS-VT. 

Technical  Approach:  This  study  will  employ  a  descriptive,  prospective  design  using  various 
instrument-testing  techniques  in  which  the  reliability  and  validity  of  the  SACMS-VT  will  be 
tested.  Once  the  initial  reliability  and  validity  is  established,  a  representative,  random  sample  of 
units  on  Ft.  Lewis  with  100  91Ws  that  are  scheduled  for  deployment  within  the  next  1-2  years  will 
be  recruited  to  take  the  SACMS-VT.  The  specific  aim  of  this  study  is  to  evaluate  the  psychometric 
properties  of  the  SACMS-VT. 

Progress:  49  subjects  were  enrolled  in  this  study.  Validity  -  Performance  skills  with  a  CVI  <  .75 
were  needle  chest  decompression,  combitube®  insertion,  and  AED  (automatic  external 
defibrillator).  The  skill  of  splinting  was  recommended  for  addition  to  the  SACMS-VT.  Reliability  - 
There  was  high  intra  and  inter-rater  agreement  on  performance  steps  and  skills  with  the 
exception  of  Bleeding/Shock  Management,  spinal  immobilization  (supine),  and  extraction.  The 
average  medics’  score  on  the  SACMS-VT  was  68%.  Subjects  tested  better  on  the  medical  skills 
than  the  trauma  skills.  When  retested,  there  was  significant  improvement  ( t  =  3.268,  d/=  7,  p  < 
.014,  two  tailed)  in  test  results.  CONCLUSIONS/RECOMMENDATIONS:  The  results  support  the 
validity  and  reliability  of  the  SACMS-VT  as  an  instrument  to  determine  beginning  level  combat 
medic  competency.  The  skills  with  lower  validity  were  related  to  the  raters’  perception  of  medics’ 
ability  and  may  change  when  test  score  are  improved.  High  reliability  may  be  related  to  the 
expertise  of  the  raters  in  this  study  and  may  change  when  raters  of  varying  skill  levels  are  used.  It 
is  highly  recommended  that  the  critical  item  passing  criteria  be  used  for  training  only  and  that  the 
critical  item  designation  be  used  for  training  only.  For  testing  purposes,  critical  items  should  be  if 
the  medic  increases  a  casualty’s  injuries  during  treatment  or  causes  death  through  inaction  or 
wrong  action. 

IMPLICATIONS:  More  research  is  needed  to  determine  the  combat  medical  readiness  of  91Ws 
Army  wide,  as  this  subject  population  was  characteristically  novice  medics  with  little  experience. 


66 


Detail  Summary  Sheets 

Department  of  Clinical  Investigation 


67 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203122  Status:  Expired 

Title:  Establishment  of  a  Limb  Regeneration  Program  Using  Notophthalmus  viridescens  (newt) 

as  the  Model  Organism  and  the  Creation  of  a  Transgenic  N.  viridescens  Strain 

Principal  Investigator:  Jeff  M.  Bullock,  M.S. 

Department:  Clinical  Investigation  Facility:  MAMC 

Associate  Investigator(s):  CPT  Jason  A.  Grassbaugh,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/10/2003  -  Sep  2006  DCI  9/13/2006 

Study  Objective:  Establish  a  limb  regneration  research  program  using  Notophthalmus 
viridenscens  as  a  model  organism.  Create  the  first  transgenic  newt,  expressing  a  LacZ  or  GFP 
marker  protein. 

Technical  Approach:  Limbs  or  blastemas  are  amputated  with  sharp  iridectomy  scissors  (or 
suitable  analog)  and  the  epidermis  is  generally  trimmed  back  to  facilitate  regeneration.  Limb 
regeneration  results  in  a  fully  formed  (albeit  small)  limb  within  4-6  weeks.  At  this  point,  animals 
will  be  returned  to  a  recovery  population  tank  until  the  regenerated  limb  is  full  size  (another  1-2 
months),  at  which  time  they  are  returned  to  the  general  population  tanks.  Newts  are  maintained 
in  dechlorinated  tap  water  at  20-26C  (or  a  salted  variant)  and  fed  live  Tubifex  worms  (or  some 
variant)  biweekly.  Animals  to  be  culled  (after  3  amputations,  aged  or  infirm)  will  be  anesthetized 
and  killed  by  decapitation.  Remains  of  non-transgenic  and  transgenic  animals  will  be  discarded  in 
accordance  with  hospital  policy.  Hormonal  stimulation  for  the  purpose  of  egg  prodcution  will 
consist  of  880-100  IU  of  human  chorionic  gonadotropin  administered  with  a  21  gauge  needle  by  IP 
injection  every  other  day  into  the  abdomen  of  an  adult  female  until  the  female  deposits  eggs.  All 
work  will  be  done  while  the  animal  is  anesthetized  in  a  solution  of  0.1%  w/v  Tricaine  (3- 
aminobenzoic  acid  ethylester  methanesulfonate  salt;  Sigma  MS222),  and  the  animals  are  allowed 
to  recover  in  a  solution  of  0.1%  W/V  sulphamerazine  for  24  hours  before  being  returned  to  a 
recovery  tank.  Both  of  thse  solutions  are  made  using  dechlorinated  tap  water. 

Progress:  This  protocol  expired  on  9-14-06  and  I  am  in  the  process  of  analyzing  several  blastemas 
from  upper  arm  and  wrist  amputation  sites  for  the  presence  of  N-cadherin  by  western  blot  analysis 
and  immunohistochemistry  of  frozen  sections.  Upon  completion  of  my  analysis  I  will  submit  a 
report  of  my  results.  If  the  results  look  encouraging  I  plan  to  write  a  companion  protocol  to  further 
investigate  the  role  N-cadherin  may  play  in  tissue  regeneration. 

An  additional  goal  of  this  protocol  was  to  creat  a  transgenic  newt.  I  have  had  limited  success  in 
this.  However  it  was  recently  reported  that  a  group  out  of  Germany  has  produced  a  transgenic 
newt  and  the  progeny  from  this  animal  are  now  available  for  purchase;  thus  negating  the  need  for 
additional  work  toward  this  goal. 


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Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206122 

Status:  Ongoing 

Title:  Profiling  of  Proteins  Extracted  from  Tissue  Taken  from  Regenerating  and  Intact 
Notophthalmus  viridescens  Limbs  Using  SELDI 

Principal  Investigator:  Jeff  M.  Bullock,  M.S. 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Matthew  J.  Martin,  MC 

Start  -  Completion:  Funding: 

9/13/2006  -  Sep  2009  DCI 

Periodic  Review: 

N/A 

Study  Objective:  Our  primary  objective  is  to  produce  a  series  of  protein  profiles  from 
regenerating  and  non-regenerating  limb  tissue.  Protein  profiles  for  each  sample  will  be  compared. 
Differences  in  the  profiles  will  be  suggestive  for  which  proteins  may  be  involved  in  tissue 
regeneration.  Candidate  proteins  will  be  targeted  for  further  research. 

Technical  Approach:  Experimental  arms  will  consist  of  the  following:  1)  Amputation  followed  by 
enervation  at  various  time  points  5,  15,  and  30  minutes  and  1,  6,  and  20-24  hours  and  2,  3,  4,  5, 
and  6  days.  2)  Enervation  only.  3)  Neural  transection  followed  immediately  by  amputation, 
followed  by  blastectomy.  Blastectomies  will  be  performed  when  the  blastemas  reach  the  early  to 
mid-late  bud  stage,  but  before  the  pallet  stage.  4)  Amputation  followed  by  blastectomy. 
Blastectomies  will  be  performed  when  the  blastemas  reach  the  early  to  mid-late  bud  stage,  but 
before  the  pallet  stage.  5)  Normal  non-regenerating  tissue  taken  from  amputated  limbs  at  time  of 
amputation.  For  all  operations  animals  will  be  anesthetized  by  soaking  in  a  cold  (4-10  CO) 
neutralized  solution  (pH  7.2  -  7.4)  of  0.1%  w/v  Ethyl  3-aminobenzoate,  methanesulfonic  acid  salt 
(MS222).  Forelimbs  will  be  amputated  at  the  mid  humerus  or  mid  radius;  ulna  region  and 
protruding  bones  trimmed  using  iridectomy  scissors  or  a  suitable  analog.  Amputation  of  the  first 
forelimb  will  be  followed  immediately  by  the  amputation  of  the  opposite  forelimb.  Amputated 
limbs  to  be  saved  will  immediately  be  put  into  cryogenic  tubes  and  snap  frozen  in  liquid  nitrogen. 
Amputees  while  still  anesthetized  will  be  given  100  1  of  Buprenex  by  IP  injection  at  a  dose  of 
(0.01-0.03  mg/kg)  diluted  to  a  concentration  of  3  X  10-4  mg/ml  with  a  lactate  ringer  solution 
adjusted  to  a  mOsmol/L  of  225  +/-  5  using  a  5/8  inch  26  gauge  needle.  Following  the  Buprenex 
injection  animals  are  placed  on  an  ice  pack  covered  with  a  paper  cloth  for  15-30  minutes  before 
allowing  them  to  warm  and  placed  back  into  an  aquarium.  Nerves  3,  4,  and  5  of  the  brachial 
plexus  are  the  main  nervous  supply  in  the  newt  forelimb.  In  animals  to  be  enervated  these  nerves 
will  be  removed  by  excision.  Using  the  tip  of  a  5/8  inch  26  gauge  needle  an  incision  will  be  made 
on  the  ventral  side  of  the  forelimb  that  runs  along  the  entire  length  of  the  limbs'  proximal  distal 
axis.  The  epidermis  and  surrounding  muscle  are  pulled  aside  to  expose  the  nerves  and  the 
rounded  bore  of  the  needle  is  inserted  beneath  the  nerve  bundles  and  pulled  along  the  length  of 
the  nerve  to  free  it  from  any  connective  tissue.  Once  the  nerve  has  been  exposed  and  freed  it  is 
excised  using  iridectomy  scissors  or  a  suitable  analog.  Excised  nerves  to  be  saved  are  immediately 
put  into  cryogenic  tubes  and  snap  frozen  in  liquid  nitrogen.  In  some  cases  nerves  3,  4,  and  5  will 
not  be  removed,  but  will  instead  be  transected  at  the  brachial  plexus.  A  small  incision  at  the 
brachial  plexus  will  be  made  with  the  tip  of  a  5/8  inch  26  gauge  needle  and  the  nerves  severed  with 
iridectomy  scissors  or  a  suitable  analog.  Animals  whose  nerves  were  removed  or  transected  while 
still  anesthetized  will  be  given  100  1  of  Buprenex  by  IP  injection  at  a  dose  of  (0.01-0.03  mg/kg) 
diluted  to  a  concentration  of  3  X  10-4  mg/ml  with  a  lactate  ringer  solution  adjusted  to  a  mOsmol/L 
of  225  +/-  5  using  a  5/8  inch  26  gauge  needle.  Following  the  Buprenex  injection  animals  are  placed 
on  an  ice  pack  covered  with  a  paper  cloth  for  15-30  minutes  before  allowing  them  to  warm  and 
placed  back  into  an  aquarium.  If  necessary,  as  determined  by  the  staff  veterinarian,  a  second  and 
third  dose  of  Buprenex  will  be  give  at  20-25  hours  post-op,  and  at  46-48  hours  post-op.  If  possible 
these  injections  will  be  given  without  anesthesia.  In  all  cases  (amputations,  enervation,  and  nerve 


69 


transections)  if  Buprenex  fails  to  provide  adequate  pain  relief  (as  determined  by  the  staff 
veterinarian)  we  plan  to  try  other  post-op  analgesics.  Possible  choices  include:  Butorphanol  at  0.2- 
0.4  mg/kg  by  IP  injection,  2%  Lidocaine  or  Bupivacaine  administered  topically  3-6  hours  post-op 
then  as  necessary  for  24-48  hours.  All  post-op  analgesic  care  decisions/changes  will  be  at  the 
discretion  of  the  staff  veterinarian.  Blastemas  are  removed  by  transecting  the  blastemas  at  the 
amputation  plane  using  iridectomy  scissors  or  a  suitable  analog.  Once  the  blastemas  have  been 
removed  they  are  immediately  put  into  cryogenic  tubes  and  snap  frozen  in  liquid  nitrogen. 
Following  blastema  removal  animals  are  placed  on  an  ice  pack  covered  with  a  paper  cloth  for  15-30 
minutes  before  allowing  them  to  warm  and  placed  back  into  an  aquarium.  No  post-op  analgesics 
will  be  given  after  removal  of  blastemas.  Depending  on  the  experimental  arm  an  animal  is  placed 
in  it  may  under  go  multiple  surgical  procedures.  However,  once  an  animal  has  been  used  in  one 
experimental  arm  it  will  not  be  used  in  a  different  experimental  arm  or  reused  in  the  same 
experimental  arm.  Animals  that  have  reached  the  end  point  of  an  experimental  arm  will  be 
euthanized  as  described  below.  Animals  to  be  euthanized  will  be  placed  in  a  0.1  to  1.0  %  w/v 
buffered  solution  (pH  7. 2-7. 6)  of  MS222  for  15-30  minutes  until  completely  sedated.  Dose  and 
length  of  time  of  MS222  exposure  will  be  at  the  discretion  of  the  staff  veterinarian.  Following 
sedation  animals  will  be  decapitated  using  iridectomy  scissors  or  a  suitable  analog.  All  tissues 
including  euthanized  animals  will  be  place  in  the  hospital  trash  for  disposal.  Tissue  to  be  saved 
will  be  snap  frozen  immediately  upon  removal.  Proteins  will  be  extracted  from  frozen  tissue  by 
sonication  and  maceration  in  a  buffered  lysis  solution  containing  protease  inhibitors.  Cellular 
debris  will  be  removed  by  centrifugation  and  protein  concentration  determined  by  colorimetric 
spectroscopy.  Protein  profiles  will  be  done  using  SELDI.  Protein  profiles  from  regenerating 
blastema  and  non-regenerating  limb  tissue  along  with  nerve  tissue  from  regenerating  and  non¬ 
regenerating  limbs  will  be  compared.  Differences  in  the  profiles  will  be  suggestive  for  which 
proteins  may  be  involved  in  tissue  regeneration.  Candidate  proteins  will  be  targeted  for  further 
research. 

Progress:  This  protocol  received  initial  approval  during  a  convened  meeting  of  the  IACUC  on  13 
September  2006,  work  will  begin  in  FY  07. 


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Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205031  Status:  Ongoing 

Title:  Proteomic  Analysis  of  Longitudinally-Collected  Maternal  Plasma  Samples:  Establishing 
the  'Pregnancy  Proteome' 

Principal  Investigator:  CPT  Michael  J.  Hartenstine,  MS 

Department:  Clinical  Investigation  Facility:  MAMC 

Associate  Investigator(s):  CPT  Patrick  M.  McNutt,  MS;  CPT  Jeremy  P.  Celver,  MS;  LTC 
Peter  G.  Napolitano,  MC;  COL  Jerome  B.  Myers,  MC;  CPT  Daniel  G.  Cuadrado,  MC;  MAJ 
Jennifer  L.  Gotkin,  MC;  Danielle  L.  Ippolito,  PhD;  CPT  Garth  S.  Herbert,  MC;  Heidi  M. 
Cederholm,  B.S.;  Aspen  M.  Bergmann,  B.S. 

Start  -  Completion:  Funding:  Periodic  Review: 

3/23/2005  -  May  2006  DCI  1/24/2006 

Study  Objective:  To  determine  the  baseline  proteome  for  a  normal  pregnancy  and  assess  the 
changes  in  protein  among  maternal  plasma  samples. 

Technical  Approach:  Investigators  propose  to  collect  samples  at  the  first  OB/GYN  physician 
visit  (  NLT  12  weeks),  during  the  second  trimester  analyte  screen  (~16-22weeks),  early  third 
trimester  (26-28weeks),  late  third  trimester  (~36-38  weeks),  upon  admission  for  labor  and  at  6-10* 
weeks  post-partum,  as  well  as  cord  blood  collected  at  delivery.  Plasma  will  be  longitudinally 
collected  from  300  pregnant  women  to  conduct  a  pilot  analysis  of  10  representative  patients  with 
uncomplicated  pregnancies  at  3  time  points.  The  preliminary  results  will  be  used  for  an  initial 
publication  and  to  pursue  more  substantive  funding  for  a  detailed  analysis.  The  samples  will  be 
available  for  collaboration  with  other  researchers  under  the  auspices  of  the  IRB,  and  under  the 
direction  of  the  research  operations  service  component  of  DCI. 

Progress:  This  protocol  remains  open  to  enrollment  with  121  patients  enrolled  at  MAMC. 
Significant  improvement  was  achieved  with  patient  enrollment  during  FY06.  Crude  samples  of 
seven  women  have  been  profiled,  which  yielded  the  beginnings  of  a  proteomic  fingerprint  of 
pregnancy.  In  addition  to  profiling  samples  from  uncomplicated  pregnancies,  several  miscarriage 
samples  have  been  profiled  and  two  specific  proteins  have  been  observed  to  be  elevated  in 
miscarriage  samples.  Collection  of  clinical  data  has  begun  on  the  patient  population  to  better 
characterize  the  samples  in  the  tissue  bank. 


71 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205044 

Status:  Ongoing 

Title:  A  Prospective  Study  of  Pseudocholinesterase  Activity 
Chronic  Pain,  Pelvic  Pain  and  Hernias 

in  Patients  with  Fibromyalgia, 

Principal  Investigator:  CPT  Patrick  M.  McNutt,  MS 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Daniel  G.  Cuadrado,  MC;  CPT  Kathleen  M.  Goings,  MC;  CPT 
Jeremy  P.  Celver,  MS;  MAJ  Brian  T.  McKinley,  MC;  CPT  Kyle  C.  Harner,  MC;  CPT  Christopher 

S.  Murphy,  MC 

Start  -  Completion:  Funding: 

3/17/2005  -  Nov  2006  DCI 

Periodic  Review: 

2/22/2006 

Study  Objective:  To  determine  if  there  is  a  correlation  between  levels  of  serum  cholinesterase 
and  acute  and  chronic  pain. 


Technical  Approach:  Five  separate  groups  will  be  analyzed  for  this  protocol.  Group  1,  hernia 
surgery,  patients  identified  with  an  inguinal  hernia  who  are  scheduled  for  surgery  with  the 
Department  of  General  Surgery  will  be  enrolled  following  detailed  pre-operative  history  and 
physical  examination  and  standard  pre-operative  laboratory  evaluation.  Those  enrolled  in  the 
study  will  fill  out  a  questionnaire  at  the  time  of  this  appointment  and  be  consented  by  a  member  of 
the  study  staff  or  resident.  During  their  routine  pre-operative  blood  draw  an  additional  3cc  purple 
top  tube  will  be  collected  and  sent  to  DCI.  There  the  specimen  will  be  centrifuged  and  the  serum 
will  be  collected  and  snap  frozen  for  analysis. 

Immediately  post-operatively,  while  in  the  recovery  room,  a  second  blood  draw  will  be  performed 
and  the  sample  likewise  sent  to  DCI  for  processing.  A  third  and  final  3cc  specimen  will  be  collected 
at  the  two  week  routine  follow-up  appointment  at  which  time  a  second  questionnaire  will  be 
completed.  Group  2-4,  Chronic  pain,  Fibromyalgia  and  Pelvic  pain,  patients  will  be  identified  at 
the  Anesthesia  pain,  Rheumatology  and  Gynecology  clinic  for  eligibility  for  entry  in  the  study 
protocol.  Those  who  meet  criteria  will  complete  the  study  questionnaire  and  undergo  a  single  3cc 
blood  draw.  The  blood  will  be  collected  in  a  3cc  purple  top  tube  and  transported  to  DCI  for 
processing.  Samples  will  be  labeled  with  a  patient  number  and  diagnosis.  Group  5,  Normal 
controls,  twenty  normal  control  patients  will  fill  out  the  study  questionnaire  and  have  a  single 
blood  draw.  The  specimen  will  be  collected  in  a  3cc  purple  top  blood  and  processed  in  DCI. 

Sample  handling  and  determination  of  PCE  activity:  Samples  will  be  collected,  processed, 
aliquoted  in  lOOuL  fractions  and  stored  at  -70  in  DCI.  SchEs  are  extremely  stable  molecules  so 
short  periods  (<12hrs)  between  collection  and  processing  should  not  interfere  with  measurements 
of  enzyme  activity.  20.0uL  of  serum  are  added  to  40.0uL  of  a  25%  sucrose  solution  containing 
lOmM  Tris-formate  (pH  9.0).  3.0uL  are  then  separated  by  vertical  flat  bed  polyacrylamide  gel 
electrophoresis  on  a  6.5%  T:  5.0%  C  gel  using  a  borate-sulfate  discontinuous  buffer  system. 
Following  electrophoresis,  the  gel  is  equilibrated  in  96mL  Tris-chloride  (pH  6.6)  in  the  presence  of 
FAST  Red  TR  or  Fast  BLUE  RR  as  the  diazonium  salt  for  five  minutes  with  gentle  agitation.  Add 
4.0mL  of  1.0%  sodium  alpha  naphthyl  acetate  in  acetone  solution  (the  substrate)  and  allow  the 
reaction  to  proceed  for  ten  minutes  at  room  temperature  with  constant  agitation.  Stop  the  reaction 
with  10%  acetic  acid.  The  resulting  insoluble  diazonium  complex  bands  mark  esterase  activity. 
Quantify  the  esterase  activity  by  quantitative  densitometry.  Densitometric  results  are  presented 
as  the  integrated  area  under  the  curve  of  each  peak  expressed  in  pixels.  The  bench  researcher  will 
have  access  to  patient  numbers  only  and  will  be  unaware  of  the  diagnosis.  Results  will  be 
tabulated  in  a  password  protected  spreadsheet  for  statistical  analysis  after  completion  of  specimen 
collection. 


72 


Progress:  Investigators  are  currently  analyzing  data  for  correlation  between 
pseudocholinesterase  activity  in  pain  patients  compared  to  normal  patients.  In  addition  we  are 
optimizing  the  pseudocholinesterase  activity  assay  and  exploring  other  assays  for  determining 
whether  changes  in  activity  are  associated  with  changes  in  protein  levels  of  pseudocholinesterase 
or  activation  state.  The  protocol  remains  ongoing. 


73 


Detail  Summary  Sheet 


Date:  30  Sep  06 

Number:  203092 

Status:  Expired 

Title:  Animal  Tissue  Use  in  Biomedical  Research  and  Training 

Principal  Investigator:  MAJ  Nancy  L  Merrill,  VC 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion: 

Funding: 

Periodic  Review: 

7/13/2003  -  Jul  2006 

DCI 

7/12/2006 

Study  Objective:  To  reduce  live  animal  use  in  biomedical  research  or  training  at  MAMC  by 
facilitating  animal  tissue  use  as  alternative  research/training  models,  wher  feasible.  Objectives 
for  individual  projects  proposed  under  this  protocol  will  be  defined  in  project  addendum. 


Technical  Approach:  In  the  past,  personnel  requesting  authorization  to  conduct  biomedical 
research  or  training  using  postmortem  animal  tissues  have  been  required  by  the  MAMC  IACUC  to 
submit  a  "stand  alone"  animal  care  and  use  protocol  that  describes  the  proposed  tissue  use, 
background,  justification,  animal  care  provisions,  literature  searched  conducted  all  in  accordance 
with  federal  animal  welfare  regulations.  Many  of  the  provisions  and  assurances  contained  in  the 
DoD-mandated  animal  use  protocol  format  did  not  apply  to  research  or  training  activities  using 
animal  tissues  only.  The  task  of  preparing  full  protocols  and  related  animal  use  reports  for  such 
activities  places  an  unnecessary  burden  on  individuals  wishing  to  reduce  live  animal  use  by 
justifiable  utilization  of  animal  tissues.  The  "alternative"  use  of  postmortem  animal  tissues  rather 
than  live  animals  (Reduction  or  Replacement)  can  be  significantly  facilitated  by  streamlining  the 
preparation,  submission,  tracking  and  reporting  of  such  research  or  training  activities  under  an 
umbrella  or  stand  protocol  that  spells  out  universal  conditions  for  animal  tissue  use.  and  identfies 
a  Principal  Investigator  (PI)  who  is  responsible  for  overseeeing  these  activities. 

Progress:  Two  amendments  were  submitted  during  FY  2006  to  collect  tissue  samples.  Muscle 
tissue  samples  were  collected  from  animals  undergoing  IACUC  approved  terminal  procedures. 
Muscle  tissue  was  used  to  test  new  tissue  preservation  media.  Blood  samples  were  collected  as 
non-terminal  procedures  from  animals  kept  at  DCI  for  training  purposes.  The  blood  samples  were 
used  for  combat  casualty  training  in  transfusion  procedures  in  protocol  204058.  Protocol  expired  as 
of  12  Jul  2006. 


74 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206109  Status:  Ongoing 

Title:  Animal  Tissue  Use  in  Biomedical  Research  and  Training 

Principal  Investigator:  MAJ  Nancy  L  Merrill,  VC 

Department:  Clinical  Investigation  Facility:  MAMC 

Associate  Investigator(s):  CPT  Joren  B.  Keylock,  MC;  James  R.  Wright,  BA,  MT  (ASCP); 

Donna  J.  Frey;  CPT  Matthew  J.  Eckert,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/12/2006  -  Jul  2006  DCI  N/A 

Study  Objective:  To  reduce  live  animal  use  in  biomedical  research  or  training  at  MAMC  by 
facilitating  animal  tissue  use  as  alternative  research/training  models,  where  feasible.  Objectives 
for  individual  projects  proposed  under  this  protocol  will  be  defined  in  project  addendum. 

Technical  Approach:  In  the  past,  personnel  requesting  authorization  to  conduct  biomedical 
research  or  training  using  postmortem  animal  tissues  have  been  required  by  the  MAMC  IACUC  to 
submit  a  "stand  alone"  animal  care  and  use  protocol  that  describes  the  proposed  tissue  use, 
background,  justification,  animal  care  provisions,  literature  searched  conducted  all  in  accordance 
with  federal  animal  welfare  regulations.  Many  of  the  provisions  and  assurances  contained  in  the 
DoD-mandated  animal  use  protocol  format  did  not  apply  to  research  or  training  activities  using 
animal  tissues  only.  The  task  of  preparing  full  protocols  and  related  animal  use  reports  for  such 
activities  places  an  unnecessary  burden  on  individuals  wishing  to  reduce  live  animal  use  by 
justifiable  utilization  of  animal  tissues.  The  "alternative"  use  of  postmortem  animal  tissues  rather 
than  live  animals  (Reduction  or  Replacement)  can  be  significantly  facilitated  by  streamlining  the 
preparation,  submission,  tracking  and  reporting  of  such  research  or  training  activities  under  an 
umbrella  or  stand  protocol  that  spells  out  universal  conditions  for  animal  tissue  use  and  identifies 
a  Principal  Investigator  (PI)  who  is  responsible  for  overseeing  these  activities. 

Progress:  Two  amendments  were  submitted  for  tissue  collection  from  other  IACUC  approved 
terminal  training  protocols.  One  was  for  muscle  tissue  to  test  transport  medium  under  different 
conditions  and  the  other  was  for  arteries,  veins,  hearts,  and  eyes  to  be  used  to  train  surgical  and 
ophthalmological  residents  in  various  techniques  specific  to  their  specialties. 


75 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203076 

Status:  Terminated 

Title:  Breeding  Colony  of  Red-Spotted  Newt  (Notophthalmus  viridescens) 

Principal  Investigator:  MAJ  Nancy  L  Merrill,  VC 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Patrick  M.  McNutt,  MS;  Steven  O.  Gibson 
Montminy 

;  SPC  Timothy  S. 

Start  -  Completion:  Funding: 

5/21/2003  -  Jun  2006  DCI 

Periodic  Review: 

5/11/2005 

Study  Objective:  To  provide  newts  of  the  appropriate  type  and  age  to  meet  the  needs  of  IACUC 
approved  protocols. 


Technical  Approach:  Newts  will  be  purchased  for  the  breeding  colony  and  raised  in  an  aquarium 
or  polycarbonate  cages  with  lids  to  prevent  escape.  Newts  will  be  provided  an  environment  that  is 
mostly  water  but  will  have  areas  to  leave  the  water,  hide  and  interact  with  each  other.  Breeding 
can  be  controlled  based  on  the  number  of  animals  in  each  container  and  the  temperature  of  the 
water.  Newts  normally  breed  in  the  fall  and  winter  when  the  water  is  colder.  Thus  by  regulating 
the  water  temperature  up  or  down  by  a  few  degrees,  mating  behavior  can  be  altered  to  regulate 
offspring  production.  Eggs  will  be  removed  from  the  adult  containers  to  prevent  them  from  being 
eaten.  Eggs  may  then  be  used  for  some  studies  while  others  will  be  allowed  to  continue  to  develop 
into  adults  for  use  as  breeders  or  for  other  IACUC  approved  protocols.  The  larva  are  terrestrial 
and  will  be  housed  in  polycarbonate  cages  with  plant  material. 

The  tracking  and  accounting  of  each  animal  will  be  part  of  the  daily  colony  management.  Each 
animal  entering  the  colony,  whether  purchased  or  propagated,  will  be  assigned  an  identification 
number.  The  animal  will  be  tracked  as  it  is  introduced  into  the  breeding  colony,  transferred  to  an 
experimental  protocol,  culled  as  excess  to  experimental  requirements,  or  lost  perinatally.  Only  the 
breeding  stock  and  animals  culled  as  excess  or  lost  perinatally  will  count  against  the  breeding 
protocol.  All  animals  transferred  to  an  experimental  or  training  protocol  will  be  counted  against 
that  protocol.  At  4  to  5  years  of  age,  breeders  will  be  euthanized  and  replaced  with  new  breeding 
stock.  New  breeding  stock  will  be  raised  for  replacement  of  breeding  stock  along  the  way.  Newts 
can  have  a  long  lifespan  but  it  is  not  uncommon  to  have  many  lost  younger  due  to  escaping  into  an 
area  where  they  become  dessicated  and  the  fact  that  newts  are  very  susceptible  to  any  toxic 
substances. 

Progress:  Notophthalmus  viridescens  did  produce  viable  eggs  for  protocol  #203122. 


76 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206091 

Status:  Ongoing 

Title:  MAMC  Rodent  and  Rabbit  Quality  Assurance  and  Sentinel  Program 

Principal  Investigator:  MAJ  Nancy  L  Merrill,  VC 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  MSG  Karen  L  Van  Loon;  SGT  Anita  J  S  Teadt; 
Phillips;  SPC  Shayla  M  Phyall;  Shelley  L  Spahn-Bridges;  Jennifer  L.  Theis 

SPC  Miemie  T 

Start  -  Completion:  Funding: 

5/10/2006  -  May  2009  DCI 

Periodic  Review: 

N/A 

Study  Objective:  The  purpose  of  this  protocol  is  to  provide  a  reliable  program  for  preventing  the 
introduction  of  adventitious  organisms  into  the  MAMC  rodent  and  rabbit  colonies.  This  will  be 
accomplished  by  sampling  species  from  selected  sources  as  they  are  received  into  the  facility. 
Suspect  groups  of  animals  will  be  quarantined  based  on  vendor  health  reports,  and  their  release 
from  quarantine  will  depend  on  results  of  quality  assurance  tests.  Continuous  health  monitoring 
or  surveillance  will  be  accomplished  by  housing  sentinel  animals  in  the  animal  rooms,  and  then 
periodically  submitting  them  for  quality  assurance  testing. 

Technical  Approach:  Experiment  1:  Sentinel  Surveillance:  Sentinel  animals  must  be  of  known 
health  status  as  indicated  below  in  para.  V.3.3.7.  For  this  purpose,  sentinel  mice  will  be  purchased 
from  JAX  or  Harlan  and  sentinel  rats  from  JAX  or  Harlan.  Sentinels  will  be  kept  in  the  colony  at 
least  one  month  before  they  are  sacrificed  and  tested,  allowing  for  any  potential  exposures  and 
subsequent  seroconversion  to  occur.  Complete  procedural  techniques  are  outlined  in  LARS  Quality 
Assurance  of  Rabbits  and  Rodents  and  Sentinel  Surveillance  SOPs. 

a.  Mice:  A  minimum  of  16  mice,  4  cages  of  4  mice  per  cage,  will  be  placed  in  each 
occupied  mouse  room  initially  (preferably  at  the  beginning  of  the  calendar  year).  During  cage 
changing  soiled  bedding  will  be  collected  from  at  least  2-3  cages  off  of  each  rack  in  the  room  and 
placed  in  a  clean  container  and  well  mixed.  The  sentinel  animals  will  be  changed  last.  A  handful 
of  the  mixed  dirty  bedding  will  be  broadcast  over  the  clean  bedding  of  a  fresh  cage  before  adding 
the  sentinel  animals  to  the  cage.  Sentinel  cages  will  be  unfiltered,  as  open  to  the  room  as  possible. 
One  cage  of  mice  will  be  sacrificed  each  quarter.  At  the  mid-point  of  the  quarter,  2  of  4  mice  in  the 
cage  will  be  sacrificed  for  serology  screening.  The  blood  will  be  pooled  from  those  2  animals  and 
sent  to  Research  Animal  Diagnostic  Laboratory  (RADIL),  University  of  Missouri.  At  the  end  of  the 
quarter,  the  remaining  2  mice  will  be  sacrificed  for  comprehensive  testing  to  include  serology  and 
pathology  by  RADIL  and  in-house  parasitology  (including  examination  of  pelts  for  external 
parasites).  Feces  from  each  room  will  be  pooled  every  six  weeks  and  submitted  for  Helicobacter 
testing  by  RADIL. 

1)  Should  any  rooms  be  used  for  breeding,  sentinel  mice  will  be  selected  from  the  indigenous 
population.  Retired  breeders  will  be  used  for  serology,  whereas  parasitology  and  pathology  will  be 
performed  on  weanlings  and  young  adults. 

2)  Extra  animals  (2  perl6  animals)  will  be  ordered  with  each  sentinel  purchase,  if  not  from 
JAX  or  Harlan.  See  section  V.1.2  These  animals  will  be  sacrificed  within  one  day  of  delivery  and 
submitted  for  Quality  Assurance  Procedures  described  in  para.  V.4.4.2. 

b.  Rats:  Sentinel  rats  will  be  managed  in  a  similar  manner,  except  they  may  be 
housed  singly.  For  long-term  housing  of  rats  (greater  than  two  months),  two  sentinel  rats  will  be 
added  to  each  occupied  rat  room  initially.  The  cages  will  contain  a  sample  of  soiled  bedding  from 
each  rack  of  animals  in  the  room  each  time  the  cages  are  changed,  similar  to  the  procedures  for 
changing  mice.  At  the  mid-point  of  the  quarter  1  rat  will  be  sacrificed  for  serology  and 
parasitology,  and  1  rat  will  be  sacrificed  for  a  comprehensive  pathologic  examination,  serology  and 
parasitology  at  the  end  of  the  quarter.  Feces  from  each  room  will  be  pooled  every  six  weeks  for 
floatation  and  testing  for  Helicobacter.  One  additional  rat  will  be  ordered  with  each  sentinel  rat 


77 


purchase.  This  animal  will  be  sacrificed  within  one  day  of  delivery  and  submitted  for  Quality 
Assurance  Procedures  described  in  V.4.4.2. 

c.  In  the  face  of  a  potential  infectious  disease  outbreak,  these  sampling  timetables 
are  compressed  under  the  direction  of  the  Chief,  Laboratory  Animal  Resources  Service,  and  are 
based  on  pathogenesis  of  the  suspected  agents. 

Experiment  2:  Quality  Assurance  Sampling:  For  the  approved  vendors  (Harlan  and  Jackson  Labs), 
the  Chief,  LARS  will  review  and  sign  diagnostic  health  reports  for  the  incoming  shipment  to 
ensure  that  the  incoming  animals  are  free  of  adventitious  organisms.  These  reports  must  be 
current  within  six  months.  For  other  vendors,  quality  assurance  will  be  performed  on  animals  from 
the  same  barrier  and/or  species/strain  as  those  ordered. 

In  the  event  that  animals  from  any  approved  vendors  are  found  to  be  the  source  of  an  adventitious 
organism  within  the  animal  colony,  two  extra  mice/rats  will  be  ordered  with  each  shipment  and 
processed  for  QA  testing  until  it  is  determined  that  additional  testing  is  no  longer  necessary.  This 
determination  will  be  based  upon  a  current  literature  review  of  the  epidemiology  and 
pathophysiology  of  the  individual  organism(s)  in  question. 

If  rodents  or  rabbits  are  received  from  an  unknown  vendor,  they  must  have  a  diagnostic  health 
report  current  within  six  months.  For  these  unknown  vendors,  additional  animals  (a  minimum  of 
3-5%,  but  not  less  than  two  animals,  at  the  discretion  of  the  Chief,  LARS,  of  the  same  strain, 
facility,  and  barrier/location  will  be  ordered  with  each  shipment  and  will  be  submitted  for  quality 
assurance  testing.  The  Chief,  LARS  will  base  his/her  decision  upon  a  current  literature  review  of 
the  epidemiology  and  pathophysiology  of  the  individual  organism(s)  in  question  and  upon  current 
quality  assurance  standards  within  the  industry. 

Data  Analysis:  Statistical  analysis  will  not  be  necessary  in  this  protocol.  Results  of  serology, 
parasitology,  and  pathologic  examination  will  be  used  to  determine  whether  or  not  adventitious 
organisms  enter  the  animal  colony,  their  spread,  and  whether  control  measures  are  effective  in 
preventing  and  eliminating  these  agents. 


Progress:  Four  C57BL  were  placed  as  sentinels  in  the  mouse  holding  room.  Two  were  submitted 
for  analysis  and  found  negative  for  pathogens.  Eight  DBA/2  were  placed  in  the  nude  mouse  room. 
Two  were  submitted  for  analysis  and  came  back  positive  for  a  newly  identified  virus,  Murine 
Norovirus  (MNV).  This  finding  was  discussed  with  the  supplier  and  their  colony  has  been  found  to 
be  positive  for  this  non-pathogenic  virus  in  immunocompetent  mice.  Transmission  to  the  nude 
mice  is  unlikely  given  methods  of  husbandry.  A  new  source  for  sentinels  will  be  identified  for 
future  use. 


78 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203075 

Status:  Terminated 

Title:  Mouse  (Mus  Musculus)  Breeding  Protocol 

Principal  Investigator:  MAJ  Nancy  L  Merrill,  VC 

Department:  Clinical  Investigation 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Patrick  M.  McNutt,  MS;  Steven  O.  Gibson 
Montminy 

;  SPC  Timothy  S. 

Start  -  Completion:  Funding: 

5/21/2003  -  May  2006  DCI 

Periodic  Review: 

5/11/2005 

Study  Objective:  To  establish  a  breeding  colony  of  mice  for  future  use  in  research  protocols. 


Technical  Approach:  LacZ+  and  normal  mice  will  be  purchased  from  Jackson  Labs  (a 
commercial  vendor  with  an  established  health  monitoring  history)  to  establish  the  breeding 
colonies.  The  colony  will  start  with  up  to  6  females  and  3  males  of  each  strain.  The  female  mice 
will  be  housed  in  groups  when  they  are  not  pregnant  or  nursing  pups.  After  they  are  used  as 
breeders  for  the  first  time,  the  male  mice  will  be  group  housed  except  when  paired  with  females  for 
mating.  Propagation  will  be  carefully  managed:  breeders  will  be  paired  only  when  there  is  a  need 
for  offspring  for  an  experimental  protocol.  Excess  offspring  not  needed  for  the  experimental 
protocol  for  which  they  were  bred  will  be  transferred  to  other  experimental  or  training  protocols 
when  possible,  used  as  sentinels  or  replacement  breeders.  If  mice  are  not  needed  for  any  other 
protocols,  the  excess  offspring  will  be  euthanized  and  tissues  from  these  excess  offspring  will  be 
made  available  to  other  investigators  for  use  on  approved  research.  When  mice  are  required  for 
use  on  an  approved  protocol,  male  and  female(s)  of  the  desired  strain  or  stock  will  be  housed 
together  for  approximately  one  week  and  then  separated.  The  female  mouse  will  be  provided  with 
nesting  material  in  addition  to  the  normal  bedding  used.  The  offspring  will  remain  in  the  cage 
with  the  female  until  they  are  used  in  an  experimental  protocol,  culled,  or  weaned  at 
approximately  21  days  of  age.  After  the  pups  are  removed,  the  female  will  be  returned  to  pair 
housing  as  soon  as  possible.  Records  will  be  maintained  to  show  the  breeding  history  of  each 
animal,  i.e.,  which  animals  were  paired,  dates  pairs  were  put  together  and  separated,  date  of  birth, 
number  of  pups  produced,  number  lost  perinatally,  number  euthanized,  etc.  The  tracking  and 
accounting  of  each  animal  will  be  part  of  the  daily  colony  management.  Each  animal  entering  the 
colony,  whether  purchased  or  propagated,  will  be  assigned  an  ID  number.  Only  the  breeding  stock 
and  animals  culled  as  excess  or  lost  perinatally  will  count  against  the  breeding  protocol.  All 
animals  transferred  to  an  experimental  or  training  protocol  will  be  counted  against  that  protocol. 
At  12  to  18  months  of  age,  breeders  will  be  euthanized  and  replaced  with  new  breeding  stock. 
Additionally,  if  we  identify  female  breeders  that  are  unable  to  effectively  rear  their  pups,  these 
animals  may  be  euthanized  prior  to  the  stated  ages.  Breeders  can  be  either  homozygous  or 
heterozygous:  thus,  progeny  need  to  be  tested  by  a  simple  enzyme  assay  (performed  on  tail/ear 
punches  in  our  laboratory)  for  the  presence  of  the  LacZ  enzyme.  Negative  homogozygotes  can  be 
incorporated  in  the  concurrent  wild-type  colony.  The  total  number  of  experimental  animals 
initially  requested  on  the  protocol  is  250/yr  for  three  years  (200  research  subjects  and  50  breeding 
animals/strain).  The  mothering  ability  of  the  females  of  both  strains  is  excellent  and  Jackson  Labs 
reports  neonatal  mortality  to  be  less  than  5%.  If  the  percentage  of  pups  that  die  or  are  euthanized 
exceeds  20%  this  will  be  reported  to  the  IACUC.  If  different  stocks  or  strains  are  required  for 
protocols  subsequently  approved  by  the  IACUC,  additional  animals  will  be  requested  by  an 
amendment  to  this  protocol  or  by  separate  protocol. 

Progress:  Breeding  colony  started  with  29  mice  and  14  wild  type  were  purchased  to  maintain 
colony.  A  total  of  315  wild  type  mice  and  35  Rosa  mice  were  weaned  and  transferred  to  protocol 
205080. 


79 


Detail  Summary  Sheets 

Hospital  Dental  Clinic 


80 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203116  Status:  Ongoing 

Title:  Host  Response  Gene  203014  in  Military  Populations 
Principal  Investigator:  MAJ  Scott  W.  Burgan,  DC 

Department:  Dentistry  Facility:  MAMC 

Associate  Investigator(s):  LTC  Paul  0.  Francis,  DC;  Richard  P.  Darveau,  Ph.D.;  MAJ  Douglas 
R.  Dixon,  D.M.D.,  M.S.D;  COL  (Ret)  Robert  B.  O'Neal,  DMD,  MEd,  MS;  LTC  Edward  B.  Fowler, 
DC;  Frank  A.  Roberts,  D.D.S.,  Ph.D.;  Beverly  Dale,  Ph.D. 

Start  -  Completion:  Funding:  Periodic  Review: 

9/12/2003  -  Sep  2007  DCI  8/29/2006 

Study  Objective:  To  determine  the  incidence  of  polymorphisms  (mutations)  in  bacterial  receptors 
between  periodontitis-affected  and  periodontally  healthy  dental  patients. 

Technical  Approach:  This  study  will  look  at  a  single  nucleotide  polymorphisms  (SNP's)  found  in 
hTLR  and  other  host  response  genes  that  will  be  examined  for  their  association  with  periodontitis 
in  the  Hispanic  and  African  American  military  population.  Approximately  450  patients  will  be 
enrolled  in  this  study  here  at  MAMC  225  periodontically  healthy  and  225  periodontitis-affected 
that  are  18  years  of  age  and  older.  The  frequency  of  different  TLR  pleomorphisms  found  in  the 
populations  will  be  determined  for  their  association  to  periodontitis  using  genomic  DNA  isolated 
from  cheek  swab  samples  and  compared  for  binomial  proportions  in  periodontally  healthy  and 
diseased  subjects.  This  information  will  aid  the  army  in  identifying  those  individuals  at  risk  for 
developing  periodontitis  and  will  contribute  to  better  health  care  by  providing  new  information 
concerning  the  molecular  basis  of  increased  susceptibility  to  and  severity  of  periodontal  disease. 

Progress:  This  protocol  remains  ongoing  with  only  30  samples  gathered  during  FY06.  The 
continuing  challenge  is  in  having  personnel  for  sample  gathering.  With  the  high  OPS  Tempo  at 
Fort  Lewis  priorities  have  often  been  in  other  areas.  There  has  also  been  a  loss  of  some  personnel 
from  the  UW  side  of  the  house.  The  nature  of  this  study  is  such  that  there  is  no  problem  with  an 
extended  period  of  sample  gathering.  It  is  taking  longer  than  anticipated  but  is  still  a  viable  and 
important  study  to  continue. 


81 


Detail  Summary  Sheets 

Department  of  Emergency  Medicine 


82 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204087  Status:  Terminated 

Title:  A  Prospective  Study  on  the  Effects  of  Ginkgo  Biloba  on  Bleeding  Times 
Principal  Investigator:  MAJ  Jimmy  L.  Cooper,  MC 

Department:  Emergency  Medicine  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Wesley  G.  Zeger,  MC;  Benjamin  B.  Betteridge,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

9/14/2004  -  Jul  2004  DCI  6/28/2005 

Study  Objective:  To  determine  if  gingko  biloba  significantly  affects  the  bleeding  times  in  young 
healthy  volunteers. 

Technical  Approach:  Twelve  healthy  volunteers  will  be  enrolled  in  this  prospective  study.  Each 
subject  will  serve  as  their  own  control.  Baseline  bleeding  times  will  be  drawn  using  the  Simplate 
test  procedure.  Each  subject  will  take  gingko  biloba  for  one  week  and  then  have  a  repeat  bleeding 
time  done.  This  data  will  then  be  analyzed  using  the  pair  t-test  to  determine  if  gingko  biloba 
significantly  affects  bleeding  times. 

Progress:  The  protocol  was  eventually  terminated  by  the  Chief,  Department  of  Emergency 
Medicine  in  June  2006,  as  the  Simplate  test  procedure  was  discontinued  at  MAMC  and  it  was  no 
longer  feasible  to  conduct  the  study.  Four  subjects  were  enrolled  during  FY05. 


83 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206063  Status:  Ongoing 

Title:  A  Randomized  Study  of  Capnography  in  Emergency  Department  Procedural  Sedation 
Principal  Investigator:  MAJ  Mark  A.  Denny,  MC 

Department:  Emergency  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Joseph  P.  Mazzoncini,  MC;  LTC  David  A.  Della-Giustina,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/7/2006  -  Apr  2007  Oridion  via  The  Geneva  Foundation  N/A 

Study  Objective:  To  determine  if  capnographic  data  recognizes  respiratory  depression  during 
emergency  department  sedations  that  are  not  clinically  recognized  and  whether  these  events  are 
clinically  important. 

Technical  Approach:  This  study  is  a  prospective,  blinded,  randomized  trial  evaluating 
emergency  physicians'  use  of  capnography  during  consecutive  procedural  sedations  on  patients 
who  sign  informed  consent  to  participate.  Approximately  22  emergency  physicians  would  be  asked 
to  consent  for  this  trial.  The  physician  may  or  may  not  have  access  to  the  capnographic  data  with 
each  sedation.  The  physician  will  then  complete  the  sedation  as  typical.  The  emergency  physician 
should  continuously  evaluate  the  patient  during  the  sedation  as  they  normally  would,  however,  if 
not  blinded  to  the  capnographic  data,  they  may  use  this  to  assist  in  their  decision  making 
processes.  The  nurse  observing  the  sedation  will  record  the  time  to  recovery  and  have  the  patient 
fill  out  the  visual  analog  scales  evaluating  injection  pain  recall,  procedural  recall,  and  patient 
satisfaction.  The  physician  completing  the  sedation  will  record,  level  of  sedation,  number  of 
clinically  recognized  respiratory  depression  events,  recognized  complications,  clinician 
interventions,  and  physician  satisfaction.  Study  investigator  will  analyze  the  stored  capnographic 
data  looking  for  unrecognized  complications  and  respiratory  depression  events.  The  groups  will  be 
compared  by  complication  rates,  incidence  of  interventions,  incidence  of  respiratory  depression 
events,  level  of  sedation,  time  to  recovery,  injection  pain,  procedural  recall,  physician  satisfaction, 
and  patient  satisfaction.  A  p-value  of  less  than  0.05  will  be  considered  statistically  significant. 
Data  will  be  analyzed  using  chi  square,  ANOVA,  Kruskal-Wallis,  and  Mann- Whitney  U-test 
methods. 

Progress:  This  protocol  is  open  to  enrollment,  with  no  patients  enrolled  during  FY06.  The  data 
recording  device  is  not  functioning  properly  and  has  been  sent  back  to  the  manufacturer. 
Enrollment  will  be  initiated  when  the  data  recording  device  is  working. 


84 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206050  Status:  Terminated 

Title:  Magnesium  Sulfate  for  the  Prevention  of  Etomidate  Induced  Myoclonus  in  Emergency 

Department  Procedural  Sedation 

Principal  Investigator:  MAJ  Mark  A.  Denny,  MC 

Department:  Emergency  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Joseph  P.  Mazzoncini,  MC;  LTC  Benjamin  P.  Harrison,  MC; 

CPT  Joshua  A.  Carr,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

Never  approved  Oridion  via  The  Geneva  Foundation  N/A 

Study  Objective:  To  determine  if  pretreatment  with  magnesium  sulfate  is  effective  in  preventing 
etomidate  induced  myoclonus  during  emergency  department  procedural  sedation.  To  determine  if 
capnographic  data  recognizes  complications  during  emergency  department  sedations  that  are  not 
clinically  recognized  and  whether  these  events  are  clinically  important. 

Technical  Approach:  This  study  is  a  prospective,  double-blind,  placebo-controlled  trial 
evaluating  the  usefulness  of  pretreatment  with  magnesium  sulfate  to  reduce  myoclonus  induced 
by  etomidate  sedation  in  emergency  department  patients  18  years  of  age  or  older  who  need 
procedural  sedation.  Patients  will  be  randomized  to  two  groups  of  58  patients  each.  The  clinicians 
will  be  randomized  to  be  blinded  or  not  to  capnographic  data.  Patients  will  receive  either  placebo 
or  magnesium  sulfate  ninety  seconds  prior  to  sedation  with  etomidate.  The  nurse  observing  the 
sedation  will  record  the  time  to  recovery  and  have  the  patient  fill  out  the  visual  analog  scales 
evaluating  injection  pain  recall,  procedural  recall,  and  patient  satisfaction.  The  physician 
completing  the  sedation  will  record  myoclonus  incidence,  level  of  myoclonus,  level  of  sedation, 
recognized  complications,  unrecognized  complications,  clinician  interventions,  and  physician 
satisfaction.  The  groups  will  be  compared  by  percentage  of  myoclonus,  level  of  myoclonus  (mild, 
moderate,  severe),  level  of  sedation,  time  to  recovery,  complication  rates,  intervention  rates, 
etomidate  injection  pain,  procedural  recall,  physician  satisfaction,  and  patient  satisfaction.  A  p- 
value  of  less  than  0.05  will  be  considered  statistically  significant.  Data  will  be  analyzed  using  chi 
square,  ANOVA,  Kruskal-Wallis,  and  Mann-Whitney  U-test  methods. 

Progress:  Soon  after  initial  IRB  approval  with  stipulations  January  2006,  the  PI  terminated  this 
study  due  to  issues  with  administration  of  Magnesium  IV  push  when  it  was  determined  not  to  be 
feasible  clinically. 


85 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206028  Status:  Completed 

Title:  Application  of  the  Wells  Criteria  to  determine  Pretest  Probability  of  Pulmonary 
Embolism:  A  Retrospective  Review  of  the  practices  of  the  Madigan  Army  Medical  Center 
Department  of  Emergency  Medicine 

Principal  Investigator:  CPT  Gregory  M.  Johnston,  MC 


Department:  Emergency  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Phu  Tan  Nguyen,  MC;  LTC  Benjamin  P.  Harrison,  MC 

Start  -  Completion: 

12/14/2005  -  Mar  2006 

Funding:  Periodic  Review: 

DCI  N/A 

Study  Objective:  To  determine  if  MAMC  emergency  residents/staff  are  making  use  of  explicit 
criteria,  i.e.  Wells  criteria,  versus  utilizing  an  empirical  method,  i.e.  drawing  upon  past  experience, 
when  determining  the  pretest  probability  of  pulmonary  embolism  and  to  enhance  awareness  of  the 
clinical  utility  of  the  Wells  criteria,  and  thereby  optimize  the  care  of  patients  by  preventing  the  use 
of  inappropriate  diagnostic  tests. 

Technical  Approach:  Emergency  Department  charts  will  be  inspected  for  the  presence  of  a 
history  of  the  present  illness  (to  account  for  immobilization,  or  hemoptysis),  vital  signs  (to  account 
for  heart  rate),  past  medical  history  (to  account  for  malignancy,  previous  deep  venous  thrombosis 
or  pulmonary  embolism,  or  recent  surgical  intervention),  and  physical  exam  (to  account  for  the 
presence  of  suspected  deep  venous  thrombosis)-all  noted  components  of  the  Wells  criteria.  It  is 
imperative  to  note  that  charts  lacking  any  of  these  findings  will  be  considered  empirically 
assessed. 

Progress:  This  protocol  was  reported  completed  in  June  2006.  To  date,  300  charts  met  all 
inclusion  criteria  for  the  study;  24  cases  of  deviation  from  appropriate  risk  stratification  were 
identified:  8%  empiric  risk  stratification: 

5  with  positive  d-dimer  and  no  follow-up  study  (none  of  patients  signed  out  AMA) 

9  with  low  pre-test  probability  that  went  straight  to  CTPA;  1  with  positive  CTPA  for  PE:  37.5% 

8  with  moderate  pretest  probability  that  underwent  d-dimer  testing  prior  to  CTPA:  33% 

2  with  moderate  pretest  probability  with  d-dimer  testing  (all  negative)  and  no  additional  testing 

Of  the  300  charts  reviewed,  a  total  of  24  documented  cases  of  pulmonary  embolism  were  noted.  Of 
the  24  cases,  4  were  inappropriately  risk  stratified-with  2  of  the  4  cases  experiencing  a  delay  in 
disposition  secondary  to  inappropriate  risk  stratification.  The  PI  noted  that  this  is  preliminary 
data  that  is  subject  to  additional  analysis  before  conclusions  can  be  drawn.  It  can  be  confidently 
posited,  however,  that  the  data  indicates  that  additional  resident  education  would  prove  to  be 
beneficial. 


86 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206059  Status:  Ongoing 

Title:  Causes  and  consequences  of  patients  who  left  a  busy  Army  Medical  Center  Emergency 

Department  prior  to  evaluation  by  a  qualified  health  care  provider 

Principal  Investigator:  CPT  Adam  S.  Nielson,  MC 

Department:  Emergency  Medicine  Facility:  MAMC 

Associate  Investigator(s):  Christopher  S.  Kang,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

1/31/2006  -  Mar  2006  DCI  N/A 

Study  Objective:  The  purpose  of  this  study  is  to,  first,  describe  the  characteristics  if  the  large 
number  of  patients  who  register  for  care  at  the  MAMC- ED,  then  subsequently  leave  prior  to 
evaluation  by  a  qualified  provider.  Describing  the  characteristics  of  these  patients  should  help 
identify  where  the  MAMC  health  care  system  can  make  quality  improvement  changes  to  improve 
patient  health  care  and  access  to  a  qualified  provider.  Secondly,  the  nature  of  the  acuity  of  the 
illnesses  or  injuries  that  this  population  of  patients  represents  will  be  described  to  determine  if 
patients  with  severe  illness  are  being  permitted  to  leave  prior  to  evaluation,  subjecting  the 
hospital  and  it's  providers  to  unnecessary  liability.  Patients  will  be  contacted  to  determine  the 
outcomes  of  their  illnesses;  i.e.,  did  the  patients  seek  care  elsewhere,  return  to  the  MAMC-ED, 
hospitalized,  or  did  the  illness/injury  improve  on  its  own. 

Technical  Approach:  Patients  who  leave  the  Madigan  Army  Medical  Center-Department  of 
Emergency  Medicine,  prior  to  being  evaluated  will  be  contacted  by  phone  by  the  investigators  and 
asked  a  standardized  series  of  questions  regarding  the  nature  of  their  illness,  what  they  have  done 
to  address  it,  why  they  left  the  emergency  department  prior  to  formal  evaluation,  and  what  could 
have  been  done  to  prevent  their  leaving. 

Progress:  Nearly  200  patients  participated  in  this  protocol;  although  less  than  the  original  goal, 
the  current  number  is  larger  than  past  studies  both  referenced  and/or  reviewed.  Data  analysis  will 
be  initiated  to  see  if  statistical  significance  has  been  achieved  or  whether  or  not  the  study  should 
resume.  A  more  accurate  assessment  should  be  available  by  the  end  of  the  year. 


87 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206078  Status:  Ongoing 

Title:  Emergency  Medicine/Combat  Trauma  Management  Training  Using  Animal  Models 
(Domestic  Goat/  Capra  hircus,  Pig/Sus  scrofa) 

Principal  Investigator:  MAJ  Bradley  N.  Younggren,  MC 

Department:  Emergency  Medicine  Facility:  MAMC 

Associate  Investigator(s):  LTC  Benjamin  P.  Harrison,  MC;  MAJ  Brandon  K.  Wills,  MC; 
Christopher  S.  Kang,  MD;  MAJ  Robert  B.  Blankenship,  MC;  MAJ  Melissa  L.  Givens,  MC;  CPT 
Jacob  A.  Roberts,  MC;  CPT  Todd  F.  Baker,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

4/12/2006  -  Mar  2009  DCI  N/A 

Study  Objective:  To  effectively  train  providers  combat-relevant  resuscitative  skills,  focusing  on 
preservation  of  life,  limb,  critical  organ  function,  and  casualty  stabilization. 

Technical  Approach:  Training  will  utilize  both  inanimate  (e.g.  mannequin,  cadaver,  Sim  Man, 
etc.)  and  live,  anesthetized  animal  models.  Whenever  feasible,  inanimate  models  will  be  used  in 
place  of  live  animals.  Animal  species  used  for  this  protocol  will  include  goat  and  pig. 

Progress:  Three  training  labs  were  held  in  FY  2006,  using  18  animal  models  and  training  84 
emergency  medicine  residents  in  emergency  medicine  and  combat  casualty  procedures.  Training 
is  further  enhanced  by  the  use  of  simulation  models  at  the  Anderson  Simulation  Center.  During 
the  course  of  a  three  year  residency,  1st  year  residents  progress  from  trainees  to  instructors  by 
their  3rd  year.  Residents  graduate  with  tangible  improvement  of  skills  necessary  to  perform 
emergency  medicine  and  combat  casualty  procedures. 


88 


Detail  Summary  Sheets 

Department  of  Family  Medicine 


89 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205133  Status:  Ongoing 

Title:  Prevalence  of  Hypertension  in  Active  Duty  Service  Members 
Principal  Investigator:  COL  Gary  W.  Clark,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  LCDR  Brian  A.  Smoley,  MC,  USN 

Start  -  Completion:  Funding:  Periodic  Review: 

9/7/2005  -  Dec  2005  DCI  8/14/2006 

Study  Objective:  To  use  screening  blood  pressure  measurements  collected  during  mandatory 
wellness  screenings  to  estimate  the  prevalence  of  hypertension  in  a  population  of  active  duty 
service  members  at  Fort  Lewis. 

Technical  Approach:  This  will  be  a  retrospective,  cross-sectional  analysis  of  data  collected  on 
approximately  10,000  active  duty  service  members  who  presented  for  wellness  screenings  through 
the  I  Corps  Readiness  and  Outcomes  Wellness  Service  (ICROWS)  between  January  1  and 
December  31,  2004.  Data  on  measured  blood  pressure  and  self-reported  age,  rank,  gender, 
race/ethnicity,  and  use  of  blood  pressure  medications  will  be  collected  from  the  ICROWS  database 
without  any  inclusion  of  or  reference  to  individual  identifying  information.  Measured  blood 
pressure  and  self-reported  use  of  blood  pressure  medications  will  be  used  to  estimate  the 
prevalence  of  hypertension  in  the  study  population.  Age-specific  and  age-adjusted  prevalence  of 
hypertension  will  be  reported  using  descriptive  statistics.  Relationships  between  hypertension  and 
demographic  variables  will  be  explored  through  bivariate  and/or  multivariate  analyses. 

Progress:  Data  on  15,391  study  subjects  has  been  analysed  to  estimate  the  prevalence  of 
hypterension  in  the  study  population.  A  draft  of  the  analysis  is  currently  undergoing  AMEDD 
public  affairs  review  prior  to  being  submitted  for  credit  toward  completion  of  a  MPH  degree  at  the 
University  of  Washington.  The  researchers  anticipate  keeping  the  protocol  open  for  an  additional 
year  in  order  to  allow  for  potential  protocol  modifications  involving  the  collection  of  additional  data 
to  facilitate  secondary  analyses.  Presentation  of  the  results  and/or  submission  for  publication  in  a 
peer-reviewed  journal  are  anticipated  within  the  year. 


90 


Detail  Summary  Sheet 


Date:  30  Sep  06 

Number:  205124 

Status:  Ongoing 

Title:  Racial  Differences  in  Health  Outcomes  for  Adults  with  Diabetes 

in  a  Military  Setting 

Principal  Investigator:  LTC  Telita  Crosland,  MC 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion: 

8/23/2005  -  Jul  2006 

Funding: 

DCI 

Periodic  Review: 

8/10/2006 

Study  Objective:  To  evaluate  health  outcomes  for  diabetic  patients  based  on  race  in  a  military 
setting. 

Technical  Approach:  This  study  is  a  quantitative  cross-sectional  analysis  of  approximately  5000 
adult  patients  in  the  MAMC  diabetic  database.  Data  to  be  recorded  inlcudes:  race,  age,  rank,  low 
density  lipoproteins,  hemoglobin  AlC,  blood  pressure,  micro  albumin,  and  number  of  clinic  visits. 
Descriptive  statistical  analysis  will  be  used  to  determine  if  there  is  a  statistical  and  clinical 
difference  in  health  outcomes  in  the  diabetic  patient  based  on  age. 

Progress:  This  protocol  has  completed  data  collection  and  analysis,  but  remains  ongoing  to 
complete  final  manuscript. 


91 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204117  Status:  Ongoing 

Title:  Impact  of  the  Sole  Prescriber  Program  on  use  of  Opioid  Medications  and  Quality  of  Life 

Principal  Investigator:  COL  Diane  M.  Flynn,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  COL  Guy  P.  Runkle,  MC;  Steven  J.  Konicek,  MD;  Nancy  A. 

Poffenberger,  PAC,  Ph;  Claudia  N.  Swenson,  PhD;  Gary  J.  Revello,  RPh;  Helen  E.  Holt,  ARNP; 

LTC  Mary  T.  Bennett,  AN;  MAJ  Elizabeth  C.  Shanley,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/31/2004  -  Dec  2004  DCI  8/14/2006 

Study  Objective:  This  protocol  is  designed  to  determine  if  enrollment  of  Madigan  patients 
identified  as  being  high  utilizers  of  narcotic  medication  into  a  sole  prescriber  program  results  in  a 
decrease  in  escalation  of  narcotic  use  and  an  improvement  in  patient  satisfaction.  Secondary 
objectives  include  determination  of  the  impact  of  the  sole  prescriber  program  on  continuity  of  care, 
utilization  of  services  and  quality  of  life. 

Technical  Approach:  An  estimated  50  MAMC  patients  who  have  received  more  than  7 
prescriptions  from  the  MAMC  pharmacy  for  opioid  medications  per  quarter  during  all  of  the  first 
three  quarters  of  FY2004  will  be  randomized  into  two  groups:  (1)  immediate  and  (2)  delayed 
enrollment  in  the  Sole  Prescriber  Program.  Patients  randomized  for  immediate  enrollment  will  be 
enrolled  starting  1  October  2004.  Delayed  enrollment  will  begin  1  February  2005.  The  groups  will 
be  compared  with  regard  to  monthly  dosage  of  opiod  medications  expressed  in  morphine 
equivalent  dosage,  number  of  prescribers  of  narcotics  per  patient,  and  several  measures  of 
utilization  of  clinical  services.  In  addition,  patient  satisfaction  and  quality  of  life  will  be  measured 
at  baseline  and  after  three  months  in  both  groups. 

The  following  dependent  variables  will  be  compared  between  study  groups  using  the  paired  t-test: 
(1)  Change  in  morphine  equivalent  dosage  of  narcotics,  (2)  Mean  number  of  prescriptions  for 
narcotics  per  patient  per  quarter,  (3)  Mean  number  of  prescribers  of  narcotics  per  patient  per 
quarter,  (4)  Mean  number  of  ER  visits  per  patient  per  quarter,  (5)  Mean  total  MAMC  visits  per 
patient  per  quarter,  (6)  Mean  total  visits  to  health  care  facilities  in  community  billed  to  TRICARE 
per  patient  per  quarter,  and  (7)  Score  on  quality  of  life  survey.  The  following  binary  dependent 
variables  will  be  compared  between  study  groups  using  the  McNemar's  test:  (1)  At  least  one  visit 
to  primary  care  provider  per  quarter  (Yes/No),  and  (2)  Is  a  narcotic  agreement  recorded  in  the 
electronic  medical  record  (Yes/No).  The  5-item  patient  satisfaction  survey  will  be  analyzed  using 
the  Wilcoxin- Signed  rank  test. 

Progress:  Investigators  have  performed  initial  analysis  of  results  on  16  subjects,  but  have  not  yet 
performed  statistical  analysis.  The  protocol  remains  ongoing  to  complete  analysis  and  final  write 
up. 


92 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206105  Status:  Ongoing 

Title:  Implementation  of  an  Office-Based  Screening  Tool  to  Improve  Adherence  with 
Recommended  Preventive  Services  in  Primary  Care 

Principal  Investigator:  COL  Diane  M.  Flynn,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  COL  Gary  W.  Clark,  MC;  MAJ  Ross  E.  Colt,  MC;  LTC  Kathryn  K. 
Ellis,  MC;  CPT  Andrea  S.  Otto,  MC;  Janet  0.  Schertzer;  John  G.  Meyer,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

7/5/2006  -  Dec  2007  DCI  N/A 

Study  Objective:  To  determine  if  the  use  of  a  questionnaire  and  written  instructions  at  every 
primary  care  visit  to  assess  adherence  with  recommended  preventive  services  will  increase  rates  of 
recommended  preventive  services. 

Technical  Approach:  Beginning  1  July  2006,  all  patients  presenting  for  care  at  Madigan  Family 
Medicine  Clinics  will  be  asked  to  complete  a  preventive  services  checklist  to  determine  if  they  are 
up  to  date  on  recommended  preventive  services.  The  nurse  or  nursing  assistant  who  screens  the 
patient  will  assist  the  patient  in  completing  the  questionnaire  as  needed,  will  distribute 
appropriate  educational  materials  as  indicated  and  will  order  indicated  labs  and  studies  under  the 
primary  care  provider's  name.  The  provider  who  sees  the  patient  will  perform  any  indicated 
examination  and  order  any  indicated  labs  or  studies  as  time  permits.  If  time  does  not  permit 
addressing  preventive  services,  the  patient  will  be  instructed  to  make  a  follow  up  appointment  for 
a  periodic  physical  examination.  Rates  of  adherence  with  recommended  preventive  services  will  be 
compared  between  the  pre-intervention  and  post-intervention  periods  between  patients  seen  in  the 
Gold  Team  and  those  seen  in  other  Family  Medicine  Clinic  teams.  Data  will  be  prepared  by  the 
Health  Outcomes  section  and  will  be  devoid  of  patient  identifiers. 

Progress:  This  protocol  began  enrollment  on  11  Sep  2006.  Since  that  date,  front  desk  clerks  have 
been  instructed  to  distribute  the  screening  questionnaire  to  all  adult  patients  who  seek  care  on  the 
Family  Medicine  Clinic  Gold  Team  (exclusive  of  sick  call  patients). 


93 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205130 

Status:  Ongoing 

Title:  Use  of  Pedometers  Among  Healthcare  Providers  in  a  Large  Military  Family  Medicine 
Department 

Principal  Investigator:  CPT  Kevin  M.  Kelly,  MC 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Robert  C.  Oh,  MC;  MAJ  Alvin  Y.  Tiu,  MC 
Crosland,  MC;  CPT  Jarret  E.  Sands,  MC 

;  LTC  Telita 

Start  -  Completion:  Funding: 

8/30/2005  -  Aug  2006  DCI 

Periodic  Review: 

8/29/2006 

Study  Objective:  To  determine  the  affect  of  a  pedometer  exercise  program  on  the  level  of  physical 
activity  of  health  care  providers  in  a  primary  care  clinic. 


Technical  Approach:  This  study  sets  out  to  determine  the  affect  of  a  pedometer  exercise 
program  on  the  level  of  physical  activity  of  health  care  providers  in  a  primary  care  clinic. 
Residents,  faculty,  and  mid-level  providers  in  the  MAMC  Family  Medicine  Department, 
approximately  seventy  total  subjects,  will  be  enrolled  in  the  study.  Study  subjects  will  be 
evaluated  for  baseline  physical  activity  level  category  with  the  International  Physical  Activity 
Questionnaire  (IPAQ)  and  baseline  daily  step  count.  They  will  be  given  a  pedometer  and 
instructions  on  increasing  their  daily  activity  level.  Their  daily  step  count  will  be  followed  for  six 
weeks.  The  IPAQ  will  be  repeated  post  intervention.  A  pre  and  post  intervention  BMI  and  blood 
pressure  will  be  also  measured.  The  change  in  number  of  steps  taken  per  day,  METS/day,  and 
physical  activity  category  (sedentary,  low  active,  somewhat  active,  active,  highly  active)  will  be 
statistically  analyzed  correlated  to  independent  variables  of  age,  BMI,  and  blood  pressure. 
Differences  between  staff,  residents,  and  mid-level  providers  will  also  be  evaluated. 

Progress:  This  protocol  closed  to  enrollment  with  50  providers  (subjects)  enrolled.  The  subjects 
completed  their  six  week  pedometer  course  and  returned  their  surveys  and  log  books  to  the 
principal  investigator.  The  information  has  been  entered  into  a  database;  study  staff  is  in  the 
process  of  analyzing  the  data  and  writing  up  the  project.  No  adverse  events  occurred.  Anticipate 
study  completion  within  the  next  two  months. 


94 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206019  Status:  Completed 

Title:  Pediatric  Obesity  in  a  Military  Family  Medicine  Clinic 
Principal  Investigator:  LCDR  Sandra  L.  Kimmer,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion:  Funding:  Periodic  Review: 

11/28/2005  -  Aug  2006  DCI  N/A 

Study  Objective:  The  specific  aims  of  this  study  is  to  measure  the  prevalence  of  pediatric  obesity 
and  overweight  in  children  ages  6-11  enrolled  at  Madigan  Army  Medical  Center  Family  Medicine 
Clinic  and  to  discover  the  relationship  between  pediatric  obesity  in  this  population  and  race, 
sponsors  active  duty  status,  and  socioeconomic  status  (SES)  as  measured  by  the  sponsor's  rank.  An 
additional  phase  of  this  study  is  to  determine  the  percentage  of  those  children  who  meet  criteria 
for  obesity  based  on  BMI  for  age  that  have  not  been  formally  diagnosed. 

Technical  Approach:  ICDB  records  for  all  children  who  were  age  6-11  and  enrolled  in  the 
Madigan  Army  Medical  Center  Family  Medicine  Clinic  during  2004  will  be  reviewed.  Because  age, 
sex,  height,  and  weight  are  required  to  calculate  the  BMI  percentile  for  age  and  sex  and  thus 
determine  whether  or  not  a  child  is  obese,  only  those  children  who  had  a  clinic  visit  in  2004  during 
which  both  height  and  weight  were  recorded  will  be  selected  for  this  study.  If  more  than  one  visit 
meets  these  criteria,  data  from  the  most  recent  visit  only  will  be  used  to  calculate  the  BMI  percent 
for  age  and  sex. 

Progress:  This  protocol  was  reported  completed  in  July  2006.  Excerpt  of  results: 

Of  the  668  subjects  in  the  study  cohort,  97  (14.5%)  met  the  diagnostic  criteria  for  obesity.  An 
additional  92  (13.8%)  children  were  clinically  overweight.  The  mean  BMI%  for  the  overweight  and 
obese  children  was  93.8%  (SD=4.22).  The  average  age  for  these  children  was  9.19  year  (SD=1.67). 
The  one-sample  binomial  test  was  used  to  compare  the  14.5%  obesity  rate  found  in  this  study  to 
the  15.3%  rate  reported  among  6-11  year  olds  in  the  1999-2000  NHANES  study.  These 
percentages  were  not  significantly  different  (p=.307).  The  prevalence  of  overweight  (13.8%)  was 
also  not  significantly  different  from  the  1999-2000  NHANES  prevalence  of  15%  (p=.202). 

The  largest  difference  in  weight  status  between  the  genders  was  seen  in  the  overweight  category. 
Of  the  overweight  children,  58  (63.0%)  were  male  and  34  (36.9%)  were  female.  Overall,  males  had 
a  16.4%  prevalence  of  overweight  and  a  14.7%  prevalence  of  obesity.  Female  prevalence  rates  were 
10.8%  and  14.3%  respectively.  Chi-square  analysis  did  not  show  a  statistically  significant 
difference  in  overweight  or  obesity  based  on  gender  (p=.102).  Almost  24%  of  11  year  olds  in  this 
study  were  clinically  obese.  Overweight  was  highest  among  10  year  olds  with  18.8%  of  the  cohort 
being  clinically  overweight.  Increased  age  was  the  only  independent  variable  to  show  a 
statistically  significant  relationship  to  weight  status  (p=.017). 

Of  the  97  subjects  who  met  the  diagnostic  criteria  for  obesity,  only  12  had  a  formal  diagnosis  of 
obesity  on  their  medical  record.  Only  one  of  the  92  overweight  children  was  formally  diagnosed. 
This  rate  of  diagnosis,  6.9%  (13  out  of  189  children),  is  significantly  different  from  the  80% 
diagnosis  rate,  which  was  considered  acceptable  (p<.001).  The  average  BMI  percentile  for  those 
children  diagnosed  (98.3%,  SD=1.52)  was  similar  for  males  was  (98.4%,  SD=0.98)  and  females 
(98.2%,  SD=1.83).  The  mean  BMI%  for  children  diagnosed  was  higher  than  that  of  children  who 
met  criteria  for  overweight  or  obesity  but  were  not  diagnosed  (93.8%,  SD=4.22).  This  difference  in 
BMI%  was  not  statistically  significant  (p=.466) 


95 


More  females  were  diagnosed  (10.1%)  than  males  (4.5%)  although  this  difference  was  not 
significant  (p=.135).  The  association  between  the  type  of  provider  seen  and  whether  or  not  the 
overweight  child  was  formally  diagnosed  approached  significance  (p=.076).  More  nurse 
practitioners  diagnosed  overweight  and  obese  children  (16.1%)  than  physicians  (7.8%)  or 
physician's  assistants  (3.1%).  The  frequency  of  visits  to  a  provider  did  not  impact  whether  or  not 
the  diagnosis  was  made  (p=.398).  Although  health  problems  are  common  in  overweight  children, 
children  in  this  cohort  who  met  diagnostic  criteria  for  overweight  or  obesity  did  not  have 
significantly  more  visits  than  their  normal  weight  peers  (p=.276). 


96 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206048  Status:  Ongoing 

Title:  A  Randomized,  Controlled  Trial  of  Manual/Manipulative  Therapy  for  Acute  Low  Back 

Pain  in  Active  Duty  Military  Personnel:  A  Pilot  Study 

Principal  Investigator:  MAJ  Douglas  M.  Maurer,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  Scott  T.  Stoll,  D.O.,  Ph.D.;  MAJ  Charles  W.  Webb,  MC;  CPT  Jarret 

E.  Sands,  MC;  CPT  April  E.  Lynch,  MC;  CPT  Richard  J.  Geshel,  MC;  MAJ  David  L.  Brown,  MC; 

CPT  Hyrum  F.  Durtschi,  MC;  COL  Gary  W.  Clark,  MC;  CPT  Scott  P  Grogan,  MC;  Tonya  N. 

Kozminski,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

3/21/2006  -  Feb  2007  Samueli  Institute  for  Information  Biology  N/A 

Study  Objective:  To  evaluate  the  efficacy  of  conservative,  non-surgical,  manually  applied 
biomechanical  treatments  to  reduce  pain  and  improve  function  in  young  adult  active  duty  military 
personnel  with  acute  low  back  pain. 

Technical  Approach:  This  is  a  prospective,  randomized,  blinded,  controlled  clinical  trial  that 
plans  to  enrollment  male  and  female  Soldiers  ages  18-25  consecutively  from  all  military  personnel 
presenting  during  sick  call  to  the  Acute  Care  Clinic,  Department  of  Family  Medicine,  Madigan 
Army  Medical  Center,  Fort  Lewis,  Washington.  Informed  consent  will  be  obtained  from  the 
subjects  who  desire  to  participate  in  the  study  by  the  Clinical  Research  Coordinator  (CRC)  and 
assigned  randomly  to  treatment  (M/MT)  or  control  (Standard  Care)  groups.  The  Study  Evaluating 
Physician  (SEP)  will  perform  a  routine  exam  to  address  the  exclusion  criteria.  If  the  patient  is  not 
cleared  for  the  study  by  the  SEP  s/he  will  enter  routine  care  and  be  excluded  from  the  study.  If  the 
subject  is  cleared  for  the  study  by  the  SEP,  the  subject  will  be  given  an  appointment  with  a  Study 
Treatment  Provider  (STP).  The  subject  will  be  informed  of  the  study  group  assignment  and 
treatment  initiated.  All  subjects  will  be  scheduled  to  see  the  same  STP  for  all  study  treatment 
visits.  All  subjects  from  both  treatment  and  control  groups  will  see  the  SEP  for  evaluation 
regarding  modified  duty  assignment.  The  SEP  and  CRC  will  be  blinded  to  group  assignment.  For 
this  study,  standard  care  will  include  prescribed  medications  including  acetaminophen,  ibuprofen 
or  naprosyn,  cyclobenzaprine  for  up  to  one  week;  acetaminophen  with  codeine  for  up  to  1  week; 
passive  modalities  (ice,  heat)  for  symptomatic  relief;  handouts  on  back  self-care  and  exercises. 
Subjects  will  be  reevaluated  at  2  weeks  and  4  weeks  for  improvement.  The  treatment  group  will 
receive  manual/manipulative  therapy  (M/MT)  in  combination  with  standard  care.  M/MT  involves  a 
set  of  treatments  with  elements  of  both  osteopathic  manipulative  and  chiropractic  techniques  and 
sessions  will  be  given  up  to  twice  a  week  for  up  to  four  weeks. 

Pain  will  be  measured  using  the  Visual  Analog  Scale  and  quantification  of  medication  use. 
Functionality  will  be  assessed  using  the  Roland  Morris  Questionnaire,  Back  Pain  Functional 
Scale,  and  days  on  limited  duty.  Statistical  analysis  tools  will  include:  descriptive  statistics,  cross 
tabulations  and  measures  of  association,  chi-square  for  dichotomous  variables,  and  a  2x3  mixed 
factorial  ANOVA.  Three  one-way  ANOVAs  comparing  the  treatment  groups  on  pain,  functionality, 
medication  use  and  other  outcome  scores  will  be  performed  using  residualized  improvement  scores. 

Progress:  This  protocol  remains  open  to  enrollment,  with  a  total  of  12  patients  enrolled  during 
FY06.  All  12  patients  received  study  treatment,  but  one  patient  failed  to  follow-up  after  the  first 
visit  and  has  had  no  further  data  collected.  The  remaining  eleven  patients  continued  to  be 
followed.  No  adverse  events  have  occurred.  Enrollment  will  continue  with  the  goal  of  100  subjects 
completing  the  study. 


97 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205025  Status:  Completed 

Title:  Prevalence  of  Vitamin  B12  Deficiency  in  the  Type  2  Diabetic  Population 
Principal  Investigator:  CPT  Matthew  C.  Pflipsen,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Robert  C.  Oh,  MC;  MAJ  Aaron  A.  Saguil,  MC;  CPT  Derek  K. 
Seaquist,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/24/2005  -  Dec  2005  DCI  1/4/2006 

Study  Objective:  To  determine  the  prevalence  of  B12  deficiency  in  Type  2  diabetics  as 
documented  by  (1)  B12  levels  <100pg/ml  or  (2)  B12  levels  of  100-350pg/ml  plus  elevations  in  serum 
methylmalonic  acid  and  homocysteine  greater  than  3  standard  deviations  above  the  mean  of 
normal  subjects. 

Technical  Approach:  The  study  population  will  include  200  consecutive  Type  2  diabetic  patients 
older  than  45  years  of  age  presenting  to  the  Family  Medicine  Clinic.  Data  on  medication  use,  past 
medical  history,  and  nutrition  will  be  obtained  by  a  survey.  Blood  samples  will  be  collected  for 
measurement  of  serum  B12  levels.  Measurement  of  serum  methylmalonic  acid  and  homocysteine 
will  be  carried  out  on  samples  requiring  further  testing  for  diagnosis.  Descriptive  statistics  will  be 
performed  and  associations  between  patients  diagnosed  with  B12  deficiency  and  without  B12 
deficiency  will  be  analyzed  using  the  Chi-square  test,  Student  t-test  and  multiple  logistic 
regression. 

Progress:  This  protocol  completed  data  collection  during  FY06,  with  204  subjects  enrolled;  199 
who  completed  study  participation.  The  principal  investigator  has  left  MAMC;  he  reports  that 
statistical  analysis  of  the  data  remains  ongoing.  An  abstract  of  findings  was  not  available  at  the 
time  of  this  report. 


98 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206067 

Status:  Completed 

Title:  Determinants  of  Military  Medical  Student  Interest  in 

Principal  Investigator:  LTC  Irene  M.  Rosen,  MC 

Family  Medicine 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion:  Funding: 

3/27/2006  -  Nov  2006  DCI 

Periodic  Review: 

9/30/2006 

Study  Objective:  To  determine  the  factors  which  influence  military  medical  students'  interest  or 
lack  of  interest  in  the  field  of  Family  Medicine. 


Technical  Approach:  A  study  questionnaire  will  be  forwarded  via  electronic  mail  to  all  3rd  and 
4th  year  medical  students  at  the  Uniformed  Services  University  of  the  Health  Sciences  (USUHS) 
as  well  as  those  participating  in  the  Health  Professions  Scholarship  Program  (HPSP).  The  study 
subjects  will  be  asked  for  their  cooperation  with  the  questionnaire,  informed  that  participation  is 
completely  anonymous  and  voluntary,  and  asked  to  email  their  responses  back  to  the  investigator 
who  will  collect  and  analyze  all  data. 

Progress:  Overall,  35  (11.3%)  of  survey  respondents  considered  FM  to  be  their  specialty  of  choice 
at  the  time  of  survey  administration.  Twenty  (57%)  of  these  students  named  FM  as  a  specialty 
they  considered  when  entering  medical  school.  The  primary  factors  cited  by  students  choosing  FM 
were  lifestyle  and  flexibility  (71%),  personality  fit  (65%),  job  satisfaction  (65%),  continuity  of  care 
(62%),  diversity  of  patient  population  (59%),  and  the  type  of  people  who  would  be  their  future 
colleagues  (59%).  This  is  in  interesting  contrast  to  students  choosing  general  surgery  and  surgical 
specialties,  whose  primary  influencing  factors  were  overall  level  of  satisfaction  (69%)  frequency  of 
deployments  (54%),  amount  of  specialty  bonus  (45%),  and  opportunity  to  sub- specialize  (38%). 
Conclusion:  This  study  shows  that  students  choosing  FM  are  motivated  by  different  factors  than 
students  choosing  other  specialties,  and  we  may  influence  student  recruitment  by  focusing  on  the 
strengths  of  our  specialty  and  highlighting  these  strengths  during  clinical  rotations. 


99 


Detail  Summary  Sheet 


Date:  30  Sep  06 

Number:  205103 

Status:  Completed 

Title:  The  Role  of  Evidence  and  Other  Determinants  in  Resident  Discussions  of  Spirituality  with 
Patients 

Principal  Investigator:  MAJ  Aaron  A.  Saguil,  MC 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion: 

10/17/2005  -  Mar  2006 

Funding: 

DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  determine  which  factors  (including  clinical  evidence)  are  most  likely  to 
predict  whether  a  family  medicine  resident  is  likely  to  initiate  a  discussion  of  a  patient's 
spirituality.  This  study  of  family  medicine  residents  seeks  to  (1)  compare  individual  likelihood  of 
initiating  discussions  of  spirituality  vis-a-vis  discussions  of  medications,  (2)  compare  the  Spiritual 
Well-Being  Scale  (SWBS)  scores  (a  validated  surrogate  for  spirituality)  of  those  more  likely  and 
those  not  more  likely  to  initiate  discussions  of  spirituality  when  given  evidence  linking  spirituality 
with  improved  patient  outcomes,  and  (3)  analyze  which  demographic  variables  are  significant 
predictors  of  likelihood  of  initiating  discussions. 

Technical  Approach:  A  survey  containing  the  SWBS  and  questions  querying  demographic  and 
practice  characteristics  will  be  mailed  to  750  family  medicine  residents  (anticipated  response  rate 
50%,  or,  375  residents  for  ?  =  0.80  at  a  p  <  0.05).  It  will  be  mailed  in  three  iterations  to  enhance 
response.  Primary  data  collected  will  look  at  resident  likelihood  of  initiating  discussions  of 
spirituality  when  presented  with  evidence  linking  spirituality  with  positive  outcomes  (which  will 
be  compared  in  an  analytic  fashion  against  resident  likelihood  of  initiating  discussions  of  a  new 
medicine  when  presented  with  evidence  linking  the  new  medicine  to  positive  outcomes);  this  data 
will  be  analyzed  using  the  Wilcoxon  Signed-Ranks  Test.  Data  will  also  be  collected  on  the  mean 
SWBS  score  among  those  more  likely  and  those  not  more  likely  to  initiate  spiritual  discussions 
with  patients;  this  data  will  be  analyzed  with  Analysis  of  Variance  (ANOVA)  testing.  Finally,  the 
descriptive  demographic  data  will  be  collected  to  see  if  any  of  these  variables  influence  a  family 
medicine  resident's  likelihood  of  initiating  spiritual  discussions;  these  data  will  be  analyzed  using 
multiple  linear  regression. 

Progress:  Results:  Surveys  from  385  of  the  750  subjects  were  returned  complete  (51.3%).  Twenty- 
two  surveys  were  excluded;  the  adjusted  response  rate  was  49.8%.  The  sample  was  53.9%  female. 
Approximately  half  of  the  respondents  (48.9%)  were  over  30  years  of  age.  Whites  comprised  67.5% 
of  the  sample,  and  non-Christian  religious  affiliation  represented  26.2%.  Geographic  regions  were 
equally  represented.  Almost  all  residents  (97.2%)  said  that  they  would  discuss  religion  if  requested 
to  do  so  by  a  patient.  The  majority  (71.3%)  either  'strongly'  or  'moderately'  agreed  that  they  would 
initiate  discussions  of  spirituality  more  often  if  provided  with  good  evidence  that  spirituality  was 
associated  with  good  health.  Geographic  region  (p=0.004),  religion  (p=0.005),  and  SWBS  quartile 
(p<0.001),  were  significant,  independent  predictors  of  'strongly'  agreeing  that  one  would  be  more 
likely  to  discuss  spirituality.  By  subcategory,  residents  in  the  Northeast  and  Midwest  were  three 
times  more  likely  to  initiate  discussion  than  those  in  the  West.  Protestants  were  almost  four  times 
more  likely  to  do  so  that  non- Christians.  Residents  in  the  lowest  SWBS  quartile  were  less  likely  to 
discuss  spirituality  than  those  in  the  highest  quartile. 

When  directly  compared  to  likelihood  of  discussing  a  new  medication,  56%  agreed  that  they  would 
be  at  least  as  likely  to  discuss  spirituality,  given  equal  evidence  for  each.  Region  (p=0.002),  religion 
(0.002),  and  SWBS  quartile  (p<0.001)  continued  to  be  significant,  independent  predictors  of  being 
as  likely  to  discuss  spirituality  as  a  new  medication.  White  respondents  were  less  likely  to  discuss 


100 


spirituality  than  a  medication,  given  equal  evidence,  than  those  in  the  'Other'  race  category. 
Residents  training  in  the  Northeast  and  Midwest  had  higher  odds  ratios  for  being  as  likely  to 
discuss  spirituality  as  a  medication  than  those  in  the  West.  Protestants  and  'Other'  Christians  had 
higher  odds  ratios  for  being  as  likely  to  discuss  spirituality  as  a  medication  that  non- Christians. 
The  average  SWBS  score  for  residents  who  were  as  likely  to  discuss  spirituality  as  a  medication 
was  102.6  (SD  14.3),  compared  to  92.3  (SD  16.5)  for  those  who  were  not  (p<0.001). 

Conclusions:  Family  medicine  residents  are  willing  to  discuss  spirituality  if  requested  by  patients 
to  do  so.  Additionally,  given  evidence,  residents  indicate  that  they  are  more  likely  to  discuss 
spirituality  than  they  do  currently.  However,  given  equally  robust  evidence  for  each,  few  residents 
indicated  that  they  were  as  likely  to  start  discussion  of  spirituality  as  they  were  a  new  medication. 
Additional  investigations  are  needed  to  determine  the  barriers  that  prevent  the  acceptance  of 
spirituality-related  research. 


101 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206104  Status:  Ongoing 

Title:  Implementing  a  Medical  Ethics  Curriculum  in  a  Family  Medicine  Residency:  Assessment 

of  Need,  Description  of  the  Process,  and  Evaluation  of  Effectiveness 

Principal  Investigator:  LCDR  Richard  W.  Sams,  MC,  USN 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Susan  P.  Opar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/5/2006  -  Jun  2007  DCI  N/A 

Study  Objective:  The  objectives  are:  (1)  to  assess  family  medicine  residents  and  staffs  baseline 
level  of  knowledge  and  comfort  level  in  dealing  with  ethical  issues  in  medicine,  (2)  to  implement  a 
medical  ethics  curriculum  in  the  family  medicine  residency,  describe  the  curriculum's  content  and 
implementation  process  and  (3)  to  evaluate  any  gains  in  knowledge  and  comfort  level  from  the 
educational  intervention  and  participants'  perceived  value  of  the  curriculum. 

Technical  Approach:  All  faculty  and  residents  will  be  invited  by  email  (Attachment  #1)  and 
announcements  to  participate  in  the  study.  They  will  be  made  aware  that  comparisons  will  be 
made  of  their  LNA  and  post-test  curricular  survey.  The  numbered  LNA  tool  will  be  placed  in  their 
mail  boxes.  They  will  be  asked  to  return  the  completed  tools  to  the  associate  investigator's 
mailbox.  The  curriculum  will  be  implemented  by  integrating  each  45  minute  seminar  into  the 
already  existing  CME  schedule.  Four  forty-five  minute  didactic  sessions  occur  each  Wednesday 
morning  for  CME  and  GME.  Once  per  rotation  block,  a  medical  ethics  seminar  will  be  conducted 
by  the  PI  during  one  of  the  four  didactic  sessions.  The  syllabus  developed  by  the  PI  will  serve  as 
the  template  for  the  sessions.  All  members  of  the  faculty  and  residents  are  encouraged  to  attend 
the  CME  lectures  in  general.  At  the  one  year  mark  the  post-test  curricular  survey  tool  will  be 
placed  in  all  faculty  and  residents  mailboxes,  and  they  will  be  asked  to  complete  the  survey  at  that 
time.  The  post-test  curricular  surveys  will  have  the  same  number  for  each  person  who  completed 
the  LNA.  This  information  will  then  be  analyzed.  See  the  attached  curriculum,  which  contains  the 
syllabus,  LNA  and  post- test  /  curricular  survey. 

The  knowledge  portion  of  the  LNA  and  post-test  consist  of  10  multiple  choice  case-based  questions, 
with  one  correct  answer  for  each  question.  Each  case  has  a  corresponding  question  regarding  how 
comfortable  the  person  is  with  the  described  ethical  dilemma  and  how  to  resolve  it.  The  person  is 
to  respond  by  rating  his  or  her  level  of  comfort  on  a  10  point  Likert  scale.  The  LNA  and  post-test  / 
curricular  survey  assesses  the  person's  perceived  value  of  the  ethics  training  for  preparing  him  or 
her  to  address  similar  ethical  issues.  This  is  assessed  on  a  10  point  Likert  scale.  The  LNA  tool 
assesses  how  burdensome  the  LNA  was  to  complete  on  a  10  point  Likert  scale.  The  post-test  / 
curricular  survey  also  assesses  the  following:  participants  perceived  value  of  the  curriculum 
personally  and  professionally;  how  many  seminars  were  attended;  and  an  assessment  of  was  there 
too  little,  too  much  or  the  right  amount  of  emphasis  on  medical  ethics. 

Progress:  A  total  of  40  participants  enrolled,  which  included  family  medicine  staff  and  residents. 
Thirty  of  the  40  voluntarily  and  anonymously  completed  the  learning  needs  assessment  /  pre-test. 
The  data  from  this  instrument  is  currently  being  analyzed.  Four  educational  sessions  were 
completed  during  the  weekly  continuing  medical  education  time  for  the  staff  and  residents. 


102 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205132 

Status:  Completed 

Title:  Colonoscopy  by  a  Family  Physician:  A  Case  Series  Demonstrating  Healthcare  Savings 

Principal  Investigator:  MAJ  Matthew  W.  Short,  MC 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Kevin  M.  Kelly,  MC 

Start  -  Completion:  Funding: 

9/1/2005  -  Nov  2005  DCI 

Periodic  Review: 

8/22/2006 

Study  Objective:  To  illustrate  the  potential  cost  savings  to  the  military  health  care  system  by 
implementing  colonoscopy  training  in  family  medicine  residency  programs. 


Technical  Approach:  A  cost  comparison/analysis  will  be  done  to  show  significant  savings  to  the 
TRICARE  system  by  implementing  colonoscopy  training  in  family  medicine  residency  programs. 
Procedure  reports  will  be  reviewed  on  all  182  TRICARE  beneficiaries  receiving  a  colonoscopy  at 
Bayne- Jones  Army  Community  Hospital,  Fort  Polk,  LA  performed  by  a  credentialed  family 
physician  between  Sept  2003  and  May  2005.  Each  procedure  will  be  properly  coded  using  the 
standard  CPT  code  for  the  procedure,  anesthesia,  and  pathology  specimens.  Standard  E&M  codes 
used  by  civilian  gastroenterologists  in  the  Louisiana  community  will  also  be  included  to  determine 
the  total  cost.  All  reimbursable  codes  for  each  patient  will  then  be  multiplied  by  the  actual  cost 
billed  to  TRICARE  in  2004  for  the  given  procedures  and  outpatient  visits.  Data  will  show  the  total 
cost  savings  to  the  military  health  care  system  by  utilizing  a  single  family  physician  to  perform 
colonoscopies  one  half  day  a  week  at  Army  community  hospitals.  Potential  nation-wide  yearly  cost 
savings  to  TRICARE  for  civilian  gastroenterology  colonoscopy  referrals  will  then  be  determined 
using  the  average  colonoscopy  cost  and  total  number  of  civilian  referrals  in  2004  obtained  from  the 
Military  Health  System  (MHS)  Management  Analysis  and  Reporting  Tool. 

Progress:  This  protocol  was  reported  completed  in  August  2006.  A  chart  review  was  conducted  of 
all  182  colonoscopies  performed  by  a  FP  at  an  ACH  from  September  2003  to  May  2005.  The  total 
facility  cost  was  $52,632.34  ($289.19  per  colonoscopy).  The  total  referral  cost  would  have  been 
$156,197.60  ($858.23  per  colonoscopy).  Utilizing  a  family  physician  saved  the  hospital  $103,565.26 
($569.04  per  colonoscopy.  A  family  physician  trained  in  colonoscopy  saved  significant  healthcare 
dollars  at  an  Army  community  hospital  by  decreasing  civilian  gastroenterology  referrals.  Note:  the 
original  title  was  'Military  Health  System  Cost  Savings  by  Implementing  Colonoscopy  Training  in 
Family  Medicine  Residency  Programs.' 


103 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205131  Status:  Completed 

Title:  Esophagogastroduodenoscopy  by  a  Family  Physician:  A  Case  Series  Demonstrating 
Healthcare  Savings 

Principal  Investigator:  MAJ  Matthew  W.  Short,  MC 

Department:  Family  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Lloyd  A.  Runser,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/1/2005  -  Nov  2005  DCI  8/22/2006 

Study  Objective:  To  illustrate  the  potential  cost  savings  to  the  military  health  care  system  by 
implementing  esophagogastroduodenoscopy  (EGD)  training  in  family  medicine  residency 
programs. 

Technical  Approach:  A  cost  comparison/analysis  will  be  done  to  show  significant  savings  to  the 
TRICARE  system  by  implementing  diagnostic  upper  gastrointestinal  endoscopy  training  in  family 
medicine  residency  programs.  Procedure  reports  will  be  reviewed  on  all  95  TRICARE  beneficiaries 
receiving  an  EGD  at  Bayne-Jones  Army  Community  Hospital,  Fort  Polk,  LA  performed  by  a 
credentialed  family  physician  between  Sept  2003  and  May  2005.  Each  procedure  will  be  properly 
coded  using  the  standard  CPT  code  for  the  procedure,  anesthesia,  and  pathology  specimens. 
Standard  E&M  codes  used  by  civilian  gastroenterologists  in  the  Louisiana  community  will  also  be 
included  to  determine  the  total  cost.  All  reimbursable  codes  for  each  patient  will  then  be 
multiplied  by  the  actual  cost  billed  to  TRICARE  in  2004  for  the  given  procedures  and  outpatient 
visits.  Data  will  show  the  total  cost  savings  to  the  military  health  care  system  by  utilizing  a  single 
family  physician  to  perform  upper  gastrointestinal  endoscopies  one  half  day  a  week  at  Army 
community  hospitals.  Potential  nation-wide  yearly  cost  savings  to  TRICARE  for  civilian 
gastroenterology  EGD  referrals  will  then  be  determined  using  the  average  EGD  cost  and  total 
number  of  civilian  referrals  in  2004  obtained  from  the  Military  Health  System  (MHS) 

Management  Analysis  and  Reporting  Tool. 

Progress:  This  protocol  was  reported  completed  in  August  2006.  A  chart  review  was  conducted  of 
all  95  EGDs  performed  by  a  FP  at  an  ACH  from  September  2003  to  May  2005.  The  total  facility 
cost  was  $22,655.65  ($238.48  per  EGD).  The  total  referral  cost  would  have  been  $55,614.95 
($585.42  per  EGD).  Utilizing  a  family  physician  saved  the  hospital  $32,959.30  ($346.94  per  EGD). 
An  endoscopy-trained  family  physician  saved  significant  healthcare  dollars  at  an  Army  community 
hospital  by  decreasing  civilian  gastroenterology  referrals. 


104 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206080 

Status:  Ongoing 

Title:  Predicting  Intern  Performance  using  an  Objective  Structured  Clinical  Examination 

Principal  Investigator:  MAJ  Matthew  W.  Short,  MC 

Department:  Family  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Robert  B.  Blankenship,  MC; 
COL  Bernard  J.  Roth,  MC 

MAJ  Jennifer  E.  Jorgensen,  MC; 

Start  -  Completion:  Funding: 

4/18/2006  -  Aug  2007  DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  determine  if  intern  performance  on  an  Objective  Structured  Clinical 
Examination  (OSCE)  prior  to  internship  is  more  predictive  than  prior  academic  performance  in 
identifying  potential  deficiencies  in  Accreditation  Council  for  Graduate  Medical  Education 
(ACGME)  core  competencies  during  the  intern  year. 

Technical  Approach:  Sixty-one  incoming  clinical  interns  at  Madigan  Army  Medical  Center  will 
complete  an  Objective  Structured  Clinical  Examination  (OSCE)  during  their  intern  orientation. 
This  OSCE  will  evaluate  each  intern  based  on  the  Accreditation  Council  for  Graduate  Medical 
Education  (ACGME)  core  competencies  of  patient  care,  medical  knowledge,  practice-based  learning 
and  improvement,  interpersonal  and  communication  skills,  professionalism,  and  system-based 
practice.  The  objective  of  this  study  is  to  determine  if  intern  performance  on  an  OSCE  prior  to 
internship  is  more  predictive  than  prior  academic  performance  based  on  data  from  their  First  Year 
Graduate  Medical  Education  (FYGME)  application  in  identifying  potential  deficiencies  in  ACGME 
core  competencies  during  the  intern  year.  If  the  OSCE  is  more  predictive  of  internship 
performance,  deficiencies  in  ACGME  core  competencies  identified  during  this  examination  could 
be  remedied  earlier  to  ensure  successful  completion  of  internship  and  result  in  more  competent, 
caring  physicians. 

Progress:  This  is  an  educational  protocol  unrelated  to  patient  care.  A  total  of  61  new  interns  took 
the  incoming  Objective  Structured  Clinical  Examination  (OSCE),  evaluating  the  six  ACGME  core 
competencies.  All  data  from  this  initial  exam  has  been  compiled  on  a  spreadsheet  to  be  analyzed. 
Program  directors'  prediction  of  performance  was  also  obtained  prior  to  the  exam  and  another 
progress  report  on  the  intern's  performance  will  be  obtained  in  January.  The  OSCE  will  be 
repeated  at  the  end  of  the  year,  5/6  June  2207,  and  the  program  directors'  final  evaluations  of 
intern  performance  will  be  collected  at  that  time. 


105 


Detail  Summary  Sheets 

Graduate  Medical  Education 


106 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205090  Status:  Ongoing 

Title:  Attitudes  and  Perceptions  of  Refractive  Surgery  Among  ROTC  Cadets  Presenting  for  a 
Flight  Physical  and  Self-Reported  Barriers  Towards  Having  Refractive  Surgery  to  Correct  Visual 
Acuity  and  Becoming  Medically  Qualified  for  Army  Aviation 

Principal  Investigator:  CPT  John  H.  Boden,  MC 

Department:  GME  Facility:  MAMC 

Associate  Investigator(s):  MAJ  John  A.  Edwards,  MC;  ETC  Mark  L.  Nelson,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/2/2005  -  Jun  2006  DCI  5/22/2006 

Study  Objective:  To  identify  attitudes  and  perceptions  ROTC  cadets  applying  for  Army  aviation 
have  towards  refractive  surgery.  This  protocol  will  also  attempt  to  identify  any  perceived  barriers 
to  receiving  an  exception  to  policy  after  having  refractive  surgery. 

Technical  Approach:  This  study  will  identify  attitudes,  and  perceptions  ROTC  cadets  have 
towards  refractive  surgery,  in  addition  to  identifying  any  perceived  barriers  cadets  might  have 
towards  receiving  an  exception  to  policy  after  having  refractive  surgery.  The  study  will  include 
ROTC  cadets  who  will  undergo  a  flight  physical  medical  examination  in  the  year  2005.  The  sample 
population  size  will  be  approximately  600  ROTC  cadets.  Cadets  will  answer  simple  questions  on  a 
questionnaire  given  to  them  prior  to  having  their  flight  physical.  Analysis  of  answers  provided  on 
questionnaires  will  include  correlation  between  subjects  understanding  of  Army  policy  on 
refractive  surgery,  level  of  interest  in  becoming  branch  aviators,  and  understanding  of  the  process 
entailed  in  receiving  an  exception  to  policy  after  having  refractive  surgery. 

Progress:  This  protocol  remains  ongoing.  A  total  of  approximately  640  cadets  applying  for  flight 
status  during  warrior  forge  2005  completed  the  study  questionnaire.  Data  from  the  questionnaires 
has  been  tabulated  and  data  analysis  is  currently  being  worked  on. 


107 


Detail  Summary  Sheets 

Health  Outcomes  Management  Division 


108 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205108  Status:  Ongoing 

Title:  The  Deployment  of  Physical  Therapy  for  Combat:  A  Description  of  the  Process  and 

Outcomes 

Principal  Investigator:  John  G.  Meyer,  MD 

Department:  Outcomes  Facility:  MAMC 

Associate  Investigator(s):  LTC  Mona  0.  Bingham,  AN;  MAJ  Daniel  M.  Jayne,  MC;  CPT  Brian 

W.  Jovag,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/21/2005  -  May  2006  DCI  6/29/2006 

Study  Objective:  The  overall  goal  of  this  study  is  to  describe  injuries  and  the  impact  of  providing 
physical  therapy  evaluation  and  treatment  intervention  prior  to  and  during  combat  deployment  for 
a  brigade  (BDE)  of  soldiers.  There  are  5  specific  aims  to  meet  this  overall  goal.  Using  data  already 
collected  from  computerized  medical  records  and  hospital  information  systems,  the  aims  of  this 
secondary  data  analysis  study  are:  (1)  Describe  a  BDE  of  soldiers  anticipating  immediate 
deployment  and  specifically  those  with  physical  orthopedic  complaints  and  injuries.  (2)  Describe 
the  impact  of  pre-deploying  screening  and  intervention  for  orthopedic  complaints  in  a  deploying 
BDE.  (3)  Compare  orthopedic  health  and  injuries  of  soldiers  in  an  AD  BDE  versus  soldiers  in  an 
Army  National  Guard  (ARNG)  BDE.  (4)  Describe  the  impact  of  physical  therapy  care  provided  in 
the  field  environment  for  a  combat  BDE  during  a  combat  deployment.  (5)  Compare  pre-deployment 
Health  Risk  Assessment  II  (HRA  II)  results  to  post-deployment  HRA  II  results. 

Technical  Approach:  For  this  retrospective  study,  data  will  be  obtained  from  the  computerized 
medical  records  available  at  Madigan  Army  Medical  Center  (MAMC)  and  other  health  information 
system  collected  as  part  of  the  SRP.  The  population  of  soldiers  assigned  to  the  81st  BDE  and  the 
3rd  BDE  (and  additional  units  who  provided  support  or  were  supported  by  the  BDEs  during  this 
deployment)  who  completed  the  Soldier  Readiness  Process  (SRP)  prior  to  deployment,  immediately 
post  deployment,  and  90-days  post  deployment  will  be  examined  to  meet  the  study  goals.  This 
number  is  anticipated  to  be  no  more  than  75%  of  the  BDEs.  However  descriptive  data  from  the 
SRP  process  on  the  Health  Risk  Appraisal  II  (HRA  II)  of  both  BDEs  will  be  collected  to  adequately 
describe  the  differences  and  similarities  between  the  2  BDEs.  Data  will  be  collected  on  a  number  of 
outcome  variables  including:  demographic  data,  and  number  of  solders  in  BDE  who  self-reported 
pain,  made  PT  self-referrals,  SRP  PT  referrals,  returned  via  Medical  evacuation,  seen  for 
healthcare  in  theater  by  PT  and  other  PCP.  Other  outcome  variables  include:  lost  work  time, 
medical  convoy  hours,  number  of  PT  treatment  procedures,  number  of  injuries,  type  of 
injury/diagnosis,  time  soldier  not  able  to  perform  combat  mission,  number  of  follow-up  physical 
therapy  visits,  profile  type  and  length,  pain  level  as  determined  by  physical  therapist,  final 
disposition,  and  HRA  II  limited  activity  answers. 

The  analysis  plan  includes  a  number  of  different  analysis  techniques  to  answer  the  research 
questions/objectives.  SPSS  will  be  used  to  run  all  descriptive  statistics  (means,  standard 
deviations,  percentages).  To  compare  orthopedic  health  and  injuries  of  soldiers  in  an  AD  BDE 
versus  soldiers  in  an  Army  National  Guard  BDE],  Chi-square  will  be  used  for  categorical  variables 
and  either  T-tests  or  Mann- Whitney  U  tests  for  measured  variables  to  determine  relationships. 
ANOVA  will  be  used  to  determine  relationships  for  interval  data.  To  compare  pre-deployment 
Health  Risk  Assessment  II  (HRA  II)  results  to  post-deployment  HRA  II  results],  Chi-square  will  be 
used  for  categorical  variables  and  either  T-tests  or  Mann-Whitney  U  tests  for  measured  variables 
to  determine  relationships.  ANOVA  Repeated  Measures  will  be  used  to  determine  relationships  for 
interval  data  with  multiple  time  points  (multiple  medical  visits/injuries)  and  Cochran  Q. 


109 


Progress:  Initiation  of  this  protocol  was  significantly  delayed  due  to  PCS  moves  of  two  study 
investigators.  This  study  will  resume  data  analysis  during  FY07. 


110 


Detail  Summary  Sheets 

Cardiology  Service,  Department  of  Medicine 


111 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202300  Status:  Ongoing 

Title:  CardioSEAL  Septal  Occlusion  System  (HUD) 

Principal  Investigator:  COL  David  T.  Schachter,  MC 

Department:  Medicine/Cardiology  Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion:  Funding:  Periodic  Review: 

3/11/2002  -  Dec  2004  Nitinol  Med  Tech  via  HDE  1/24/2006 

Study  Objective:  Humanitarian  Use  Device 

Technical  Approach:  The  CardioSEAL  Septal  Occlusion  System  is  approved  as  an  HUD  for  the 
indication  of  patent  foramen  oval  closure  (PFO).  MAMC  investigators  trained  to  deploy  this  device 
must  submit  certificates  of  training  and  updated  curriculum  vitae  to  the  Chairman,  IRB.  Use  of 
the  device  will  be  tracked  per  21  CFR  814.124(a). 

Progress:  Nine  patients  have  undergone  successful  implantation  of  the  CardioSEAL  device 
without  complications,  one  during  FY06.  All  patients  had  strokes/TIA  and  evidence  of  PFO  by 
bubble  study.  No  further  stroke/TIA  events  have  been  detected  in  any  of  the  nine  patients. 


112 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201300  Status:  Ongoing 

Title:  Jostent  Coronary  Stent  Graft  (HUD) 

Principal  Investigator:  COL  David  T.  Schachter,  MC 

Department:  Medicine/Cardiology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Bruce  R.  Kenwood,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/25/2001  -  Sep  2010  Jomed  via  HDE  8/28/2006 

Study  Objective:  Humanitarian  Use  Device 

Technical  Approach:  The  Jostent  Coronary  Stent  Graft  is  approved  as  an  HUD  for  the 
indication  of  arterial  perforation.  Physicians  trained  to  deploy  the  stent  will  be  added  as  associate 
investigators  upon  receipt  of  documentation  of  training.  Use  of  the  device  will  be  tracked  per  21 
CFR  814.124(a). 

Progress:  This  Humanitarian  Use  Device  was  not  utilized  during  FY06.  A  Jostent  device  was 
inserted  in  a  patient  for  a  perforated  saphenous  vein  graft  in  April  2005.  The  patient  is  doing  well 
and  continues  to  be  followed. 


113 


Detail  Summary  Sheets 

Hematology/Oncology  Service,  Department 

of  Medicine 


114 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206113  Status:  Ongoing 

Title:  CTSU  E5202:  A  Randomized  Phase  III  Study  Comparing  5-FU,  Leucovorin  and 
Oxaliplatin  versus  5-FU,  Leucovorin,  Oxaliplatin  and  Bevacizumab  in  Patients  with  Stage  II 
Colon  Cancer  at  High  Risk  for  Recurrence  to  Determine  Prospectively  the  Prognostic  Value  of 
Molecular  Markers 

Principal  Investigator:  LTC  Tommy  A.  Brown,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 
David  E.  McCune,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/28/2006  -  Aug  2011  SWOG  via  Henry  M.  Jackson  Foundation  N/A 

Study  Objective:  The  primary  objective  of  this  study  is  to  demonstrate  an  improvement  in  3-year 
disease-free  survival  for  high  risk  stage  II  colon  cancer  patients  randomly  assigned  to  5-FU, 
leucovorin,  and  oxaliplatin  (FOLFOX)  versus  FOLFOX  plus  bevacizumab. 

Secondary  objectives  of  this  study  are  to:  Compare  overall  survival  between  regimens;  further 
identify  the  toxicities  of  the  regimens;  prospectively  determine  the  impact  of  tumor  biological 
characteristics  on  the  survival  of  patients  with  stage  II  colon  cancer. 

Technical  Approach:  In  this  study,  patients  determined  to  be  high-risk  by  the  molecular 
analysis  will  receive  chemotherapy  +/-  bevacizumab.  A  total  of  3610  patients  will  be  enrolled  in 
this  study,  with  up  to  10  patients  per  year  enrolled  at  MAMC.  Baseline  assessment  will  include 
history  and  physical,  vitals  and  performance  status,  CBC,  Chemistry,  LFTs,  CEA,  PT,  PTT,  INR, 
urine  protein/creatinine  (UPC)  ratio,  and  serum  pregnancy  test  if  applicable.  All  eligible, 
consenting  participants  will  have  a  block  of  resected  tumor  sent  to  a  central  lab  for  biology-based 
risk  assessment.  Patients  found  to  be  low  risk,  will  be  registered  to  Arm  C,  the  observation  arm. 
Patients  found  to  be  high  risk,  will  be  randomized  to  receive  either:  ARM  A  (control  arm):  5-FU, 
leucovorin,  and  oxaliplatin  (FOLFOX  regimen)  IV  every  2  weeks  x  12  or  ARM  B:  FOLFOX  plus 
bevacizumab  IV  every  2  weeks  x  12,  followed  by  bevacizumab  alone  for  12  additional  treatments 
(IV  every  2  weeks).  Patients  will  be  followed  every  3  months  for  2  years,  every  6  months  for  Year  3 
through  Year  5,  and  then  every  12  months  thereafter  for  a  total  of  10  years.  Follow-up  will  include 
physical  exam,  performance  status,  CEA,  and  colonoscopy  and  biopsy  where  indicated. 

Progress:  This  greater  than  minimal  risk  protocol  received  initial  approval  with  stipulations 
during  the  convened  IRB  meeting  on  25  July  2006.  PI  response  to  CIRO  review  remains  pending 
at  the  time  of  this  report. 


115 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206023  Status:  Ongoing 

Title:  A  Multi-Center,  Randomized,  Phase  3  Study  of  Iodine  1-131  Tositumomab  Therapeutic 
Regimen  Versus  Ibritumomab  Tiuxetan  Therapeutic  Regimen  for  Subjects  with  Relapsed  or 
Transformed  Follicular  Non-Hodgkin's  Lymphoma 


Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Antonio  G.  Balingit,  MC;  Jane  E.  Besich-Carter,  BS,  BCNP 

Start  -  Completion:  Funding: 

4/13/2006  -  Jan  2011  GlaxoSmithKline  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

N/A 

Study  Objective:  This  study  will  compare  the  proportion  of  subjects  treated  with  Iodine  I  131 
tositumomab  therapeutic  regimen  who  experience  any  Grade  3/4  hematological  adverse  event  with 
the  proportion  of  subjects  treated  with  ibritumomab  tiuxetan  therapeutic  regimen  who  experience 
this  type  of  adverse  event.  Subjects  in  this  study  must  have  had  at  least  three  prior  therapies  for 
either  follicular  non-Hodgkin's  Lymphoma  (NHL)  or  follicular  NHL  that  has  transformed  to 
diffuse  large  cell  lymphoma. 

The  secondary  objectives  for  efficacy  are  comparison  of  the  confirmed  overall  response  rate, 
confirmed  complete  response  rate,  and  duration  of  response,  as  well  as  event-free  survival, 
progression  free  survival,  time  to  next  treatment,  and  overall  survival  between  the  two  treatment 
groups.  Establishment  of  the  non-inferiority  of  Iodine  I  131  tositumomab  compared  to 
ibritumomab  tiuxetan  based  on  event-free  survival  will  be  the  principal  secondary  objective. 

The  secondary  safety  objectives  are  safety  comparisons  between  the  Iodine  I  131  tositumomab  and 
ibritumomab  tiuxetan  treatment  groups  for  the  following  events:  Infusional  toxicities  (all  and 
Grade  3/4),  Gastrointestinal  toxicities  (all  and  Grade  3/4),  Immune  response  (Human  Anti-Murine 
Antibody  [HAMA]),  Elevated  thyroid- stimulating  hormone  (TSH),  Myelodysplastic  syndrome 
(MDS)/acute  myelogenous  leukemia  (AML),  Serious  adverse  events  (SAEs)  related  to  cytopenia 
(bleeding  events,  neutropenic,  fever,  infections,  hospitalization  for  hematologic  supportive  care).  To 
characterize  the  safety  profile  in  the  two  treatment  groups,  including  the  frequency  of  adverse 
events,  the  duration  of  infusion,  and  tolerance  of  first  subsequent  NHL  therapy.  To  summarize 
safety  and  efficacy  outcomes  during  the  first  subsequent  treatment  encounter  for  NHL.  To 
establish  the  non-inferiority  of  confirmed  overall  response  rates  and  confirmed  complete  response 
rates  between  Iodine  I  131  tositumomab  and  ibritumomab  tiuxetan. 

Technical  Approach:  This  is  a  randomized,  multi-center,  Phase  III  study  comparing  1131 
tositumomab  (Bexxar)  versus  Y90  ibritumomab  tiuxetan  (Zevalin)  in  subjects  with  relapsed  or 
transformed  follicular  non-Hodgkin's  lymphoma  who  have  received  prior  treatment  with  rituximab 
(Rituxan).  A  total  of  350  subjects  will  be  randomized  into  two  treatment  arms,  with  up  to  10 
subjects  being  enrolled  at  MAMC.  Subjects  will  be  randomly  assigned  to  one  of  the  two  treatment 
arms.  Randomization  will  be  stratified  by  baseline  bone  marrow  involvement,  baseline  blood  count 
and  prior  fludarabine  treatment  and  conducted  separately  within  each  stratum.  Subjects  on  Arm  A 
will  be  treated  with  the  standard  Zevalin  regimen,  including  rituximab  and  radiolabeled 
ibritumomab  tiuxetan  in  two  separate  doses  for  imaging  and  therapy.  Subjects  randomized  to  Arm 
B  will  be  treated  with  the  standard  Bexxar  regimen  in  two  separate  doses  for  imaging  and 
therapy.  Subjects  in  each  arm  will  be  followed  for  ten  years  after  receiving  study  drug  (five  years 
for  efficacy  endpoints  and  ten  years  for  safety  endpoints).  After  study  drug  administration,  labs 
will  be  drawn  at  least  weekly  for  up  to  13  weeks  to  closely  monitor  hematological  toxicity. 


116 


Response  assessments  will  be  done  at  Weeks  7,  13,  26,  39  and  52  during  the  first  year,  every  six 
months  during  the  second  year,  then  annually  through  five  years  or  until  first  subsequent 
treatment.  See  schema,  protocol  page  22.  The  study  is  powered  to  detect  a  significant  reduction  of 
15%  in  Grade  3/4  hematologic  toxicity.  In  addition,  the  study  will  have  90%  power  to  establish 
non-inferiority  of  the  Bexxar  treatment  versus  Zevalin. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  no  subjects  screened  or  enrolled 
during  FY06. 


117 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205094 

Status:  Terminated 

Title:  A  Randomized,  Open-Label  Trial  Comparing  Two  Avastin™  (Bevacizumab)-Based 
Treatment  Regimens  For  The  First-Line  Treatment  Of  Metastatic  Colorectal  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

12/15/2005  -  Aug  2010  Genentech  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

6/28/2006 

Study  Objective:  To  compare  the  efficacy,  as  measured  by  progression-free  survival  (PFS),  of 
FOLFOX/Avastin  followed  by  FOLFIRI/Avastin  versus  FOLFAX/Avastin  followed  by  5- 
FU/LV/Avastin  as  first-line  therapy  for  previously  untreated  metastatic  colorectal  cancer. 
Secondary  Objectives:  (1)  to  evaluate  the  efficacy,  as  measured  by  overall  survival,  of 
FOLFOX/Avastin  followed  by  FOLFIRI/Avastin  versus  FOLFOX/Avastin  followed  by  5- 
FU/LV/Avastin  as  first-line  therapy  for  previously  untreated  metastatic  colorectal  cancer  (2)  to 
evaluate  the  tolerability  of  sequential  treatment  in  subjects  during  first-line  therapy,  as  measured 
by  time  to  first-line  treatment  response  (3)  to  evaluate  the  safety  of  an  Irinotecan/Avastin-based 
regimen  versus  5-FU/Avastin  regimen  following  abbreviated  FOLOFOX/Avastin  as  first-line 
therapy  for  previously  untreated  metastatic  colorectal  cancer,  as  measured  by  the  incidence  of 
serious  adverse  events,  selected  adverse  events,  and  treatment  discontinuation  for  reasons  other 
than  tumor  progression. 

Technical  Approach:  This  is  a  randomized,  open-label  trial  comparing  two  Avastin 
(bevacizumab)  based  treatment  regimens  for  the  first-line  treatment  of  metastatic  colorectal 
cancer.  Subjects  who  qualify  will  be  randomized  to  one  of  two  treatment  arms.  Subjects  in  both 
treatment  arms  will  receive  FLOFAX/Avastin  every  2  weeks  for  eight  cycles.  At  the  end  of  the  first 
eight  cycles,  subjects  who  have  not  experienced  disease  progression  will  receive  treatment  as 
follows:  Arm  A  subjects  will  receive  FLOFAX/Avastin  every  2  weeks  until  disease  progression  or 
unacceptable  toxicity,  at  which  point  they  will  be  discontinued  from  the  study.  Arm  B  subjects  will 
receive  5-FU/LV/Avastin  every  2  weeks  until  disease  progression  or  unacceptable  toxicity,  at  which 
point  they  will  be  discontinued  from  the  study.  All  subjects  who  have  documented  disease 
progression  will  be  discontinued  from  the  study.  Subjects  will  be  followed  for  adverse  events  for  30 
days  after  the  last  dose  of  study  treatment  or  subject  discontinuation.  Subjects  will  be  followed  for 
survival  and  post-progression  therapy  every  3  months  until  death,  withdrawal  of  consent,  or 
termination  of  the  study  by  Genentech. 

Post-progression  therapy  will  not  be  specified  by  protocol.  It  is  recommended  that  as  initial  post¬ 
progression  therapy,  subjects  in  Arm  A  receive  FOLFOX  re-induction  if  feasible  and  that  subjects 
in  Arm  B  receive  Irinotecan-based  therapy.  In  conjunction  with  post-progression  therapy,  subjects 
can  receive  biological  therapy  with  Avastin  and/or  Cetuximab  at  the  physician's  discretion. 

Subjects  will  be  monitored  during  the  entire  treatment  phase  and  will  be  followed  as  appropriate. 
Subjects  who  are  discontinued  from  treatment  for  any  reason  will  be  evaluated  30  days  after  the 
decision  to  discontinue  study  treatment. 

Progress:  This  protocol  was  terminated  by  the  Study  Sponsor  due  to  slower  than  expected  accrual 
and  an  unexpected  high  rate  of  early  discontinuation  from  study  treatment  for  reasons  not  related 
to  toxicity.  No  MAMC  subjects  were  screened,  consented  or  enrolled.  There  are  no  unreported  IND 
safety  reports  at  this  time. 


118 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206103  Status:  Terminated 

Title:  Phase  3,  Multicenter,  Multi-National,  Open-Label  Study  to  Evaluate  the  Safety  and 

Efficacy  of  Alfimeprase  in  Subjects  with  Occluded  Central  Venous  Access  Devices 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

Never  approved  Nuvelo,  Inc.  via  Henry  M.  Jackson  Foundation  N/A 

Study  Objective:  To  evaluate  the  safety  profile  of  alfimeprase  assessed  by  monitoring  of  adverse 
events  and  major  bleeding  events  for  up  to  120  minutes  following  the  final  instillation  of 
alfimeprase.  To  evaluate  the  efficacy  of  alfimeprase  measured  by  the  proportion  of  subjects  with 
re-establishment  of  a  functional  CVAD  at  15  minutes  following  the  initial  instillation  of  study 
drug,  30  minutes  following  the  initial  instillation  of  study  drug  and  30  minutes  following  the 
instillation  of  one  or  two  doses  of  study  drug. 

Technical  Approach:  This  a  Phase  3,  multicenter,  multinational,  open  label  trial  to  assess  the 
safety  and  efficacy  of  intra-luminal  alfimeprase  3.0  mg  in  subjects  with  occluded  central  venous 
assess  devices  (CVAD).  A  total  of  800  subjects  will  be  enrolled  and  up  to  20  at  MAMC.  Patients 
with  single  lumen,  multilumen,  centrally  inserted,  peripherally  inserted  and  implanted  ports  that 
are  occluded  will  be  enrolled.  They  will  receive  intra-luminal  alfimeprase  (2ml)  and  it  will  be  left 
in  the  catheter  for  up  to  30  minutes.  Re-establishment  of  catheter  function  will  be  assessed  by  an 
attempt  to  draw  3mL  of  blood  and  infuse  5mL  saline  at  5,  10,  15,  and  30  minutes  of  first  dose.  If 
patentcy  of  the  catheter  is  not  restored  after  30  minutes  of  first  dose  of  the  drug  then  a  second  dose 
will  be  administered  and  left  in  the  catheter  for  an  additional  30  minutes.  Safety  will  be  assessed 
by  monitoring  serious  adverse  events,  adverse  events  and  major  bleeding  events  for  up  to  120 
minutes  after  instillation  of  the  final  dose  of  the  drug.  Vital  signs,  venous  blood  for  laboratory 
testing  will  be  collected  at  8  to  24  hours  after  instillation  of  the  first  study  drug  dose.  After  the 
study  period  which  could  be  up  to  an  hour  the  patients  will  be  followed-up  at  2  hours  after 
instillation  of  the  final  study  drug  dose.  Again  at  8-24  hours  and  28-45  days  after  instillation  of  the 
first  study  drug  dose.  The  proportion  of  patients  with  re-establishment  of  functional  CVAD  at  15 
minutes  following  the  instillation  of  the  study  drug  will  be  the  major  efficacy  end  point. 

Progress:  This  protocol  was  terminated  27  September  2006,  prior  to  final  approval  due  to  failed 
contract  negotiations  with  the  study  sponsor.  The  study  was  never  initiated  at  MAMC. 


119 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205007  Status:  Suspended 

Title:  PSOC  2003:  A  Phase  II  Study  Evaluating  the  Efficacy  of  Gemcitabine,  Carboplatin, 
Dexamethasone  and  Rituximab  for  Previously  Treated  Lymphoid  Malignancies,  UW  Protocol 
Number  LYM. 03. 01- 


Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

2/18/2005  -  Oct  2009  NCI  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

10/24/2006 

Study  Objective:  (1)  To  determine  the  feasibility  and  safety  of 

Gemcitabine/Carboplatin/Dexamethasone  with  or  without  Rituximab  in  previously  treated 
lymphoid  malignancies.  The  primary  end-point  will  be  response  rate  (Rituximab  will  only  be 
evaluated  in  CD20  positive  malignancies).  (2)  To  determine  the  efficacy  of  the  above  regimen.  (3) 
To  determine  the  ability  to  proceed  to  blood  stem  peripheral  blood  collection  following  the  above 
regimens  the  impact  of  above  regimen  on  stem  cell  reserve.  (4)  To  determine  remission  duration. 

Technical  Approach:  PSOC  2003  is  a  multicenter  single  arm  phase  II  trial  of  Gemcitabine, 
Carboplatin,  and  Dexamethasone  in  the  treatment  of  recurrent  or  refractory  lymphoma  (including 
B-cell,  T-cell,  and  Hodgkin's  disease).  Patients  with  C020  positive  B-cell  lymphoma  will  also  be 
treated  with  Rituximab.  The  end  points  of  the  trial  include  response  rate,  duration  of  remission, 
and  the  ability  to  collect  stem  cells  for  possible  future  autologas  stem  cell  transplant.  The  goal 
accrual  of  the  study  is  51  patients  over  2  to  3  years.  We  anticipate  accruing  two  patients  per  year 
at  Madigan.  The  study  will  be  monitored  for  accrual,  adverse  events  and  patient  deaths  every  6 
months  by  the  Study  Investigator,  Dr  Ajay  Gopal  of  the  University  of  Washington  and  the  Fred 
Hutchinson  Cancer  Research  Center,  and  will  be  monitored  annually  by  the  Fred  Hutchinson 
Cancer  Research  Center  Protocol  Data  Monitoring  Committee. 

Progress:  This  protocol  remains  open  to  enrollment  with  one  patient  enrolled  at  MAMC  who 
continued  to  be  followed  during  FY06. 


120 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  89080  Status:  Terminated 

Title:  SWOG  8814  (ECOG  4188,  NCCTG  883051):  Phase  III  Comparison  of  Adjuvant 
Chemoendocrine  Therapy  with  CAF  and  Concurrent  or  Delayed  Tamoxifen  to  Tamoxifen  Alone 
in  Postmenopausal  Patients  with  Breast  Cancer  Having  Involved  Axillary  Nodes  and  Positive 
Hormone  Receptors 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/20/1989  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  8/14/2006 

Study  Objective:  To  compare  disease-free  survival  and  overall  survival  of  postmenopausal 
primary  breast  cancer  patients  with  involved  axillary  nodes  and  positive  estrogen  and/or 
progesterone  receptors  treated  with  standard  adjuvant  therapy  with  long-term  Tamoxifen  or  with 
chemoendocrine  therapy  with  CAF,  followed  by  long-term  Tamoxifen  or  with  concurrent 
chemoendocrine  therapy  with  Tamoxifen  and  CAF  and  to  compare  the  relative  toxicity  of  the  three 
therapies. 

Technical  Approach:  Tumors  must  be  pathologic  stage  Tl,  T2,  or  T3;  N;  MO  (Stage  II  or  selected 
Stage  IIIA).  Patients  must  have  histologically  proven  adenocarcinoma  of  the  breast  with  at  least 
one  positive  lymph  node  (tumor  and/or  nodes  must  not  be  fixed).  Patients  must  have  undergone  a 
radical,  modified  radical,  or  breast  sparing  procedure  plus  axillary  dissection  (level  I  or  level  II). 
Patients  with  bilateral  breast  cancer  are  ineligible.  Estrogen  and  progesterone  receptors  must  be 
assayed  and  one  and/  or  the  other  must  be  positive  by  the  institutional  laboratory  standards  of  >10 
fmol/mg  protein.  Prestudy  studies  must  reveal  no  evidence  of  metastatic  disease.  Prior  hormonal 
or  chemotherapy  is  not  allowed  and  prior  postmenopausal  estrogen  therapy  is  allowed  but  must  be 
discontinued  before  registration.  Stratification  factors  will  include:  involved  nodes  (1-3,  >4);  PgR+ 
(ER  positive  or  negative)  vs  PgR(ER  positive);  time  from  surgery  to  randomization  (<6  vs  >6 
weeks).  Patients  will  be  randomized  to  one  of  three  treatment  arms:  Arm  I:  Tamoxifen  x  5  years, 
Arm  II:  Intermittent  CAF  x  6  courses  followed  by  Tamoxifen  x  5  years,  Arm  III:  Intermittent  CAF 
x  6  courses  with  concurrent  Tamoxifen  x  5  years. 

Progress:  This  protocol  closed  to  patient  entry  in  August  1995,  with  six  patients  enrolled  at 
MAMC;  three  who  remained  in  long-term  follow-up.  The  protocol  was  terminated  during  FY06  and 
the  three  surviving  patients  will  continue  to  be  followed  under  MAMC  #99019,  SWOG  S9808: 
Long-Term  Follow-Up  Protocol:  An  Administrative  Tool. 


121 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  90027  Status:  Ongoing 

Title:  SWOG  8851  (EST  5811,  INT-0101):  Phase  III  Comparison  of  Combination  Chemotherapy 
(CAF)  and  Chemohormonal  Therapy  (CAF  +  Zoladex  or  CAF  +  Zoladex  +  Tamoxifen)  in 
Premenopausal  Women  with  Axillary  Node-Positive,  Receptor-  Positive  Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/16/1990  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  12/4/2006 

Study  Objective:  To  compare  the  recurrence  rates,  disease-free  intervals,  relative  toxicities,  and 
hormone-receptor-positive  survival  for  premenopausal  women  with  axillary  lymph  node-positive 
breast  cancer  given  adjuvant  therapy  with  combination  chemotherapy  using  cyclophosphamide, 
doxorubicin,  and  5-FU  (CAF)  alone  or  CAF  followed  by  Zoladex,  or  CAF  followed  by  Zoladex  plus 
Tamoxifen;  and  to  assess  the  effect  of  CAF,  CAF  plus  Zoladex,  and  CAF  plus  Zoladex  and 
Tamoxifen  on  hormone  levels  (LH,  FSH,  and  estradiol)  in  these  patients. 

Technical  Approach:  Patients  will  be  nonpregnant  females  who  have  undergone  excision  of  the 
primary  breast  tumor  mass,  proven  histologically  to  be  invasive  breast  adenocarcinoma  and  must 
have  one  or  more  pathologically  involved  axillary  nodes.  Patients  who  undergo  total  mastectomy 
may  receive  post-operative  radiotherapy  at  the  discretion  of  the  investigator.  Patients  who  have 
had  prior  hormonal  therapy  or  chemotherapy  for  breast  cancer  are  ineligible.  Patients  will  be 
randomized  to  CAF  alone  for  six  cycles  or  to  CAF  for  6  cycles  followed  by  monthly  Zoladex  for  5 
years,  or  to  CAF  for  6  cycles  followed  by  daily  Tamoxifen  and  monthly  Zoladex  for  5  years. 
Adjuvant  therapy  will  be  instituted  as  soon  as  possible  after  mastectomy  or  lumpectomy.  The 
interval  between  definitive  surgery  and  initiation  of  adjuvant  chemotherapy  will  not  be  >12  weeks. 
When  planned,  radiation  therapy  may  be  administered  prior  to  or  after  (within  4  weeks  of) 
completion  of  6  cycles  of  adjuvant  chemotherapy. 

Progress:  This  protocol  closed  to  patient  entry  in  February  1994,  with  6  patients  enrolled.  Three 
patients  are  deceased  and  three  remain  disease  free  and  continued  to  be  followed  at  MAMC  during 
FY06. 


122 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  90029  Status:  Terminated 

Title:  SWOG  8897  (EST-2188,  CALGB-8897,  INT-0101):  Phase  III  Comparison  of  Adjuvant 

Chemotherapy  With  or  Without  Endocrine  Therapy  in  High-Risk,  Node  Negative  Breast  Cancer 

Patients,  and  a  Natural  History  Follow-up  Study  in  Low-Risk,  Node  Negative  Patients 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/19/1990  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  12/1/2005 

Study  Objective:  To  compare  disease-free  survival  and  overall  survival  of  high  risk  primary 
breast  cancer  patients  with  negative  axillary  lymph  nodes  treated  with  standard  adjuvant 
chemotherapy  for  6  cycles;  either  CMF  (cyclophosphamide,  methotrexate,  5-FU)  or  CAF 
(cyclophosphamide,  adriamycin,  5-FU);  to  assess  the  value  of  the  addition  of  tamoxifen  for  five 
years  compared  to  no  tamoxifen  in  these  patients;  to  compare  the  toxicity  of  the  therapies;  to 
assess  the  prognostic  significance  of  DNA  flow  cytometry  in  patients  with  small,  occult  invasive 
breast  cancer  treated  by  local  therapy  only;  and  to  evaluate  the  disease-free  survival  and  survival 
of  low  risk  invasive  breast  cancer  patients  determined  by  receptor  status,  tumor  size,  and  %  S 
phase  treated  by  local  therapy  only. 

Technical  Approach:  Patients  must  have  undergone  a  radical,  modified  radical,  or  breast 
sparing  procedure  plus  level  1  and  2  axillary  lymph  node  dissection.  Patients  with  bilateral  breast 
cancer,  prior  hormonal  or  chemotherapy,  or  previous  or  concurrent  malignancy  are  ineligible.  Low 
risk  patients  will  be  followed  but  will  not  receive  adjuvant  therapy.  High  risk  patients  will  be 
randomized  to:  (1)  CMF  x  6  cycles;  (2)  CAF  x  6  cycles;  (3)  CMF  x  6  cycles  followed  by  tamoxifen;  or 
(4)  CAF  x  6  cycles  followed  by  tamoxifen.  Patients  will  start  adjuvant  chemotherapy  within  12 
weeks  of  definitive  surgery.  Patients  who  have  had  a  breast  sparing  procedure  and  axillary 
dissection  will  receive  radiation  therapy,  either  before  or  after  CMF  or  CAF  (at  the  discretion  of 
the  treating  physician).  Radiotherapy  and  tamoxifen  may  be  given  together.  Patients  will  be 
removed  from  the  study  for  unacceptable  toxicity,  development  of  local/regional  or  metastatic 
disease;  or  noncancer  related  illnesses  that  prevent  continuation  of  therapy  or  regular  follow-up. 
Patients  will  be  followed  until  death. 

Progress:  This  protocol  closed  to  patient  entry  in  January  1993,  with  six  patients  enrolled  at 
MAMC  who  remain  disease  free.  The  protocol  was  terminated  during  FY06  and  the  six  surviving 
patients  will  continue  to  be  followed  under  MAMC  #99019,  SWOG  S9808:  Long-Term  Follow-Up 
Protocol:  An  Administrative  Tool. 


123 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  90056  Status:  Completed 

Title:  SWOG  8997  (ECOG  3887):  Phase  III  Chemotherapy  of  Disseminated  Advanced  Stage 

Testicular  Cancer  with  Cisplatin  Plus  Etoposide  with  Either  Bleomycin  or  Ifosfamide 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

4/20/1990  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  2/8/2006 

Study  Objective:  To  determine  the  objective  response  rate  and  duration  of  remission  of  BEP 
compared  to  VIP  combination  chemotherapy;  to  determine  the  toxicity  of  VIP  compared  to  BEP 
combination  chemotherapy;  to  confirm  the  efficacy  and  toxicity  of  intravenous  Mesna  as  a 
urothelial  protective  agent. 

Technical  Approach:  Patients  must  have  a  histologic  diagnosis  of  advanced  disseminated  germ 
cell  tumor  and  no  prior  chemotherapy  or  radiation  therapy.  Patients  will  be  randomized  to  VIP 
(cisplatin,  ifosfamide,  mesna,  and  etoposide)  to  BEP  (cisplatin,  etoposide,  and  bleomycin).  The 
regimen  will  be  repeated  every  three  weeks  for  four  cycles.  Bleomycin  will  be  omitted  for 
postsurgery  chemotherapy  in  BEP  patients.  Patients  in  complete  remission  at  the  end  of  four 
courses  of  therapy  will  receive  no  further  treatment.  If  there  is  radiographic  or  serologic  evidence 
of  persistent  disease  and  residual  tumor  is  surgically  resectable,  surgery  will  be  performed. 
Patients  who  have  complete  or  near  complete  resection  of  residual  radiographic  abnormalities  with 
the  pathologic  finding  of  fibrosis/necrosis  and  those  who  have  complete  resection  of  mature  or 
immature  teratoma  will  receive  no  further  treatment.  Patients  who  have  complete  resection  of 
residual  disease  which  histologically  shows  viable  carcinoma  will  receive  two  more  courses  of  the 
original  induction  therapy.  If  residual  tumor  is  deemed  unresectable,  patients  will  be  followed 
monthly  until  disease  progression  with  no  further  therapy.  If  relapse  occurs  in  complete  or  partial 
responders  less  than  4  weeks  after  day  1  of  the  last  course  of  induction  therapy,  the  patient  will  be 
taken  off  study. 

Progress:  This  protocol  closed  to  patient  entry  in  April  1992,  with  one  patient  enrolled.  The 
protocol  was  reported  completed  during  FY06  when  long-term  follow-up  data  was  no  longer 
required  on  the  surviving  patient. 


124 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  97096  Status:  Ongoing 

Title:  SWOG  9059  (E1392,  INT-0126):  Phase  III  Comparison  of  Standard  Radiotherapy  versus 
Radiotherapy  plus  Simultaneous  Cisplatin,  versus,  split-Course  Radiotherapy  plus 
Simultaneous  Cisplatin  and  5-Fluorouracil,  in  Patients  with  Unresectable  Squamous  Cell 
Carcinoma  of  the  Head  and  Neck 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/16/1997  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  4/10/2006 

Study  Objective:  1)  To  compare  the  effectiveness  of  standard  radiation  therapy  alone  to  radiation 
therapy  and  simultaneous  chemotherapy  with  cisplatin  to  split-course  radiation  therapy  with 
cisplatin  and  5-fluorouracil  infusion  in  patients  with  unresectable  Stage  III  and  IV  squamous  cell 
carcinoma  of  the  head  and  neck.  Endpoints  will  include  complete  response  rate,  time  to  treatment 
failure,  and  overall  survival.  2)  To  compare  the  relative  toxicities  of  these  treatment  arms,  in  this 
patient  population.  3)  To  compare  patterns  of  relapse  or  treatment  failure  among  these  regimens. 

4)  To  further  assess  the  role,  timing,  and  success  of  surgery  in  patients  achieving  a  response  to 
non-operative  therapy. 

Technical  Approach:  Unresectable  Squamous  Cell  Carcinoma  has  a  dismal  prognosis  with  3 
year  survivals  in  the  25'  range.  Several  studies  have  shown  that  adding  chemotherapy  to  radiation 
therapy  may  improve  response  rates  and  may  allow  some  patients  to  get  surgery  after  therapy. 
There  are  two  approaches  to  adding  chemotherapy  to  radiation  therapy.  One  way  is  to  give 
concurrent  therapy  with  Cisplatinum  alone  with  combined  continuous  radiation  therapy  (A1  Sarraf 
regimen)  or  to  give  combination  Cisplatinum  and  5-FU  with  split  course  (Adelstein  Regimen). 
These  two  regimens  have  met  with  some  success  in  single  ARM  Phase  II  studies  and  have  resulted 
in  some  patients  having  subsequent  surgeries  translating  into  longer  survivals.  It  is  thus  the  aim 
of  this  study  to  evaluate  efficacy  of  three  different  regimens  with  continuous  radiation  therapy 
alone  serving  as  the  third  ARM.  Toxicities  from  these  regimens  are  reasonable. 

Progress:  This  protocol  closed  to  patient  entry  in  April  2000,  with  two  patients  enrolled.  One 
patient  died  of  progressive  disease  and  the  other  patient  remains  disease  free  and  continued  to  be 
followed  at  MAMC  during  FY06. 


125 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  93032  Status:  Ongoing 

Title:  SWOG  9061  (EST-2190,  INT  0121):  A  Phase  III  Study  of  Conventional  Adjuvant 
Chemotherapy  vs  High  Dose  Chemotherapy  and  Autologous  Bone  Marrow  Transplantation  or 
Stem  Cell  Transplantation  as  Adjuvant  Intensification  Therapy  Following  Conventional 
Adjuvant  Chemotherapy  in  Patients  with  Stage  II  and  III  Breast  Cancer  at  High  Risk  of 
Recurrence 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/7/1993  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  10/31/2006 

Study  Objective:  To  compare  the  sites  and  rates  of  recurrence,  disease-free  survival  and  overall 
survival,  and  toxicity  of  adjuvant  chemotherapy  (CAF)  with  adjuvant  chemotherapy  plus  high-dose 
therapy  with  cyclophosphamide  and  the  TEPA  with  autologous  marrow  infusion  in  patients  with 
breast  cancer  with  10  or  more  positive  lymph  nodes. 

Technical  Approach:  Patients  will  be  stratified  according  to  estrogen  receptor  status,  age,  and 
menopausal  status  and  then  randomized  to  receive  radiotherapy  plus  tamoxifen  or  high-dose 
chemotherapy  and  autologous  bone  marrow  transplantation.  Both  arms  will  receive 
cyclophosphamide  100  mg/m2  PO  X  14  days,  doxorubuicin  30  mg/m2  IV  days  1  &  8,  and  flurouracil 
500  mg/m2  IV  days  1  &  8  repeated  every  28  days  x  6  cycles  (CAF).  Patients  receiving  CAF  without 
bone  marrow  transplantation  will  begin  radiation  therapy  within  4  weeks  of  the  last  dose  of 
chemotherapy  or  when  the  WBC  >  2900  and  Platelets  >  100,000.  Patients  randomized  to  receive 
high-dose  chemotherapy  will  have  bone  marrow  harvested  no  sooner  than  4  weeks  nor  longer  than 
8  weeks  after  the  last  previous  dose  of  myelotoxic  chemotherapy.  The  CBC  must  be  normal  and  the 
bone  marrow  normocellular  and  free  of  tumor  by  bilateral  iliac  crest  biopsy  within  4  weeks  prior  to 
storage.  After  the  bone  marrow  is  harvested,  high-dose  chemotherapy  of  cyclophosphamide  6000 
mg/m2/96  hr  and  ThioTEPA  800  mg/m2/96  hr  (4  days),  will  be  given  by  continuous  infusion  over  4 
days,  days  -6  to  -2.  Autologous  bone  marrow  reinfusion  will  be  on  day  0.  Patients  receiving  BMT 
will  again  be  randomized  to  receive  GM-CSF  as  a  daily  2,  6  or  24  hour  intravenous  infusion 
beginning  2-4  hours  after  bone  marrow  infusion.  GM-CSF  will  be  initiated  at  a  dose  of  250 
mcg/m2/d.  Treatment  will  continue  until  the  patient  has  achieved  an  absolute  neutrophil  count 
(ANC)  of  =  1000  cells/ul  on  3  consecutive  days  or  a  planned  duration  of  28  days  of  treatment. 

Tamoxifen  20  mg  PO  q.d.  will  be  given  to  all  patients  who  are  estrogen  or  progesterone 
receptor  positive  after  the  completion  of  all  chemotherapy  for  5  years.  For  patients  not  randomized 
to  receive  transplant,  Tamoxifen  should  be  initiated  28  days  after  the  start  of  the  last  CAF  cycle. 
Patients  randomized  to  receive  transplant  should  begin  Tamoxifen  following  transplant  when 
WBC  >  4000  and/or  ANC  >  2000.  Patients  will  be  taken  off-study  if  there  is  development  of 
metastatic  disease  at  any  time  while  therapy  is  ongoing.  Measurement  of  effect  is  recurrence, 
disease-free  survival  or  survival  (survival  is  measured  from  the  date  of  randomization  to  date  of 
death).  At  measured  times  during  the  study  a  Breast  Chemotherapy  Questionnaire  (BCQ)  will  be 
completed  to  separately  document  the  changes  in  psychosocial  function  that  occur  on  the  two 
regimens.  Not  all  subjects  will  complete  the  questionnaire  at  all  time  points,  but  if  at  least  150  per 
arm  have  complete  data,  the  width  of  a  95%  confidence  interval  on  the  mean  change  in  scores 
would  be  about  ±  0.09.  The  BCQ  will  also  be  used  to  make  comparisons  between  regimens.  A  2 
degree  of  freedom  test  based  on  the  difference  of  the  means  of  the  36  week  evaluation  and  the 
difference  of  the  means  of  the  52  week  evaluation  will  be  used. 


126 


Progress:  This  protocol  closed  to  patient  entry  in  August  1998,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


127 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  93097 

Status:  Ongoing 

Title:  SWOG  9205:  Central  Prostate  Cancer  Serum  Repository  Protocol 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding: 

Periodic  Review: 

5/7/1993  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation 

4/10/2006 

Study  Objective:  1)  To  store  serum  of  patients  with  confirmed  adenocarcinoma  of  the  prostate 
entered  onto  clinical  trials  conducted  by  the  SWOG  Genitourinary  Committee.  2)  To  provide  the 
serum  of  the  above  patients  entered  onto  SWOG  studies  for  specific  clinical-laboratory 
investigations  outlined  on  separate  SWOG  protocols  approved  by  the  Genitourinary  Committee 
Tumor  Biology  Subcommittee. 

Technical  Approach:  This  serum  bank  is  to  provide  the  opportunity  for  study  of  new  or  existing 
markers  or  other  tests  in  a  prospective  or  retrospective  fashion,  in  order  to  test  their  usefulness  as 
diagnostic  or  management  tools  in  prostate  cancer  at  all  stages.  Specific  information  regarding  the 
nature  of  individual  tests  to  be  conducted  on  the  serum  samples  of  these  patients  will  be  described 
in  individual  protocols.  All  serum  samples  (approx.  3  -  5  cc)  will  be  collected  from  patients  in  the 
frequency  and  timing  indicated  on  specific  protocols.  Samples  will  be  spun  15  minutes  after 
collection  and  stored  at  a  minimum  of  -20°C.  Samples  will  be  frozen  and  shipped  to  the  Serum 
Bank  Coordinator. 

Progress:  This  prostate  cancer  companion  protocol  remains  open  to  enrollment  with  14  patients 
enrolled  at  MAMC,  two  during  FY06. 


128 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  93136  Status:  Ongoing 

Title:  SWOG  9221,  MDACC  ID  91-025,  INT-191-001:  Phase  III  Double-Blind  Randomized  Trial 
of  13-Cis  Retinoic  Acid  (13-cRA)  to  Prevent  Second  Primary  Tumors  (SPTs)  in  Stage  I  Non-Small 
Cell  Lung  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/2/1993  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  5/24/2006 

Study  Objective:  To  evaluate:  (1)  the  efficacy  of  13-cis-retinoic  acid  (13-cRA)  in  reducing  the 
incidence  of  SPTs  in  patients  who  have  been  treated  for  Stage  I  non-small  cell  lung  cancer  with 
complete  surgical  resection;  (2)  the  qualitative  and  quantitative  toxicity  of  13-cRA  in  a  daily 
administration  schedule;  and  (3)  compare  the  overall  survival  of  patients  treated  with  13-cRA  vs. 
patients  treated  with  placebo. 

Technical  Approach:  Patients  enrolling  into  this  study  will  be  stratified  according  to  histology,  T 
stage  and  smoking  status  then  registered  into  a  Single-Blind,  8  week  run-in  period  to  test 
compliance.  All  patients  will  receive  placebo  during  this  period.  After  Run-in  the  patients  will  be 
randomized  into  a  double-blind  trial  to  receive  13-cRA  (30  mg  p.o./d  x  3  yrs  vs.  Placebo  (30  mg 
p.o./d  x  3  yrs).  Each  group  will  have  a  4  year  follow-up  period. 

The  final  analysis  will  be  undertaken  shortly  after  seven  years.  The  primary  hypothesis  for 
the  study  is  whether  13-cRA  lowered  the  rate  of  second  primary  tumors  (SPT).  All  patients 
randomized  will  be  grouped  according  to  the  assigned  treatment.  Patients  who  are  either  purely 
lost  to  follow  up  or  died  without  a  SPT  occurring  will  be  included  in  the  actuarial  analysis  with  a 
censored  status  on  the  last  day  of  contact.  The  primary  hypothesis  of  treatment  benefit  will  be 
tested  using  the  proportional  hazards  model. 

Progress:  This  protocol  closed  to  patient  entry  in  April  1997,  with  eight  patients  enrolled  who 
remain  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


129 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  93166  Status:  Ongoing 

Title:  SWOG  9303:  Phase  III  Study  of  Radiation  Therapy,  Levamisole,  and  5-Fluorouracil  versus 
5-Fluorouracil  and  Levamisole  in  Selected  Patients  With  Completely  Resected  Colon  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/5/1993  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  8/14/2006 

Study  Objective:  To  determine  whether  5-FU,  levamisole  and  radiation  therapy  results  in 
superior  overall  survival  when  compared  to  5-FU  and  levamisole  without  radiation  therapy  in  the 
management  of  patients  with  completely  resected  pathologic  stage  T4BN0-2  colon  cancer  and 
selected  patients  with  T3N1-2  colon  cancer. 

Technical  Approach:  This  randomization  clinical  trial  will  compare  radiation  therapy,  5FU  and 
levamisole  with  5FU  and  levamisole  in  patients  with  completely  resected  colon  cancer  at  high  risk 
for  local-regional  recurrence  and  limited  risk  for  system  disease. 

We  will  compare  5FU  and  levamisole,  as  delivered  in  the  prior  intergroup  study,  with  one 
month  of  5FU  and  levamisole  followed  by  5-5  1/2  weeks  of  5FU,  levamisole,  and  local-regional  RT 
(45-50.4  Gy  in  25-28  fractions),  followed  by  43  weeks  of  5FU  and  levamisole. 

Progress:  This  protocol  closed  to  patient  entry  in  December  1996,  with  one  patient  enrolled 
during  FY95,  who  remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


130 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  94170  Status:  Terminated 

Title:  SWOG  9313:  Phase  III  Comparison  of  Adjuvant  Chemotherapy  With  High-Dose 
Cyclophosphamide  +  Doxorubicin  vs  Sequential  Doxorubicin  Followed  by  Cyclophosphamide  in 
High-Risk  Breast  Cancer  Patients  with  0-3  Positive  Nodes 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/21/1994  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  8/14/2006 

Study  Objective:  1)  To  compare  disease-free  survival,  overall  survival,  and  toxicity  of  high-risk 
primary  breast  cancer  patients  with  negative  axillary  lymph  nodes  or  with  one  to  three  positive 
nodes  treated  with  adjuvant  high-dose  chemotherapy  with  doxorubicin  plus  cyclophosphamide, 
versus  high-dose  sequential  chemotherapy  with  doxorubicin  followed  by  cyclophosphamide.  2)  To 
obtain  tumor  tissue  for  biologic  studies. 

Technical  Approach:  Women  with  primary  breast  invasive  adenocarcinoma,  will  be  randomized 
to  one  of  two  treatments:  1)  High  dose  doxorubicin  +  cyclophosphamide  x  6  cycles,  or  2)  High  dose 
sequential  doxorubicin  x  4  cycles,  followed  by  high  dose  cyclophosphamide  x  3.  Women  who  are 
postmenopausal  and  have  receptor  +  will  receive  Tamoxifen  for  5  years. 

Progress:  This  protocol  closed  to  patient  entry  in  May  1997,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  at  MAMC.  The  protocol  was  terminated  during 
FY06,  and  the  surviving  patient  will  continue  to  be  followed  under  MAMC  #99019,  SWOG  S9808: 
Long-Term  Follow-Up  Protocol:  An  Administrative  Tool. 


131 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  95003  Status:  Ongoing 

Title:  SWOG  9401:  A  Controlled  Phase  III  Evaluation  of  5-FU  Combined  with  Levamisole  and 
Leucovorin  as  Surgical  Adjuvant  Treatment  Following  Total  Gross  Resection  of  Metastatic 
Colorectal  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/18/1994  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  10/10/2006 

Study  Objective:  To  determine  in  patients  who  have  undergone  complete  gross  surgical  resection 
of  metastatic  colorectal  cancer  whether  postoperative  adjuvant  chemotherapy  with  a  new  regimen 
of  5-fluorouracil  (5-FU)  plus  leucovorin  plus  levamisole  will  result  in  improved  survival  compared 
to  postoperative  adjuvant  chemotherapy  with  a  standard  5-FU  plus  levamisole  regimen. 

Technical  Approach:  Patients  will  be  randomly  selected  to  treatment  Arm  I  or  treatment  Arm 
II.  Arm  I  consists  of  the  standard  regimen  of  5-FU  given  by  rapid  intravenous  infusion  for  5 
consecutive  days,  plus  levamisole  given  by  mouth  three  times  daily  for  three  consecutive  days 
every  other  week  for  one  year.  Arm  II  is  a  new  chemotherapy  regimen  which  adds  leucovorin  in 
addition  to  the  5-FU  and  levamisole.  5-FU  and  leucovorin  are  given  by  rapid  intravenous  injection 
for  five  consecutive  days  every  four  to  five  weeks  for  one  year.  Levamisole  is  given  by  mouth  three 
times  per  day  for  three  days  in  a  row  every  two  weeks  during  the  first  two  months,  then  every  2-3 
weeks  for  a  total  of  one  year. 

Progress:  This  protocol  closed  to  patient  entry  in  September  1996,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


132 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  95093  Status:  Ongoing 

Title:  SWOG  9402:  Phase  III  Intergroup  Randomized  Comparison  of  Radiation  Alone  vs  Pre- 

Radiation  Chemotherapy  for  Pure  and  Mixed  Anaplastic  Oligodendrogliomas 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/19/1995  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  2/8/2006 

Study  Objective:  1)  overall  survival  2)  compare  time  to  tumor  progression  between  the  two  arms 
3)  the  frequency  of  severe  (=  grade  3)  toxicities  will  be  examined.  4)  compare  quality  of  life  and 
neurologic  function  between  the  two  arms.  5)  identify  the  key  histopathologic  criteria  necessary  to 
make  the  diagnosis  of  anaplastic  oligodendroglioma  and  mix  oligo-astrocytoma;  evaluate  the 
diagnostic  and  prognostic  relevance  of  chromosomal  alterations;  evaluate  the  diagnostic  and 
prognostic  relevance  of  DNA  ploidy  and  indices  of  proliferation  including  percent  S  and  percent 
G2M;  study  the  diagnostic  and  prognostic  relevance  of  immunohistochemical  markers  of  cellular 
function  and/or  glial  development;  and  evaluate  the  transnational  relevance  of  tumor  suppressor 
genes  and  oncogenes. 

Technical  Approach:  This  is  a  non-blinded  randomized  intergroup  study  and  is  different  from 
other  randomized  trials  for  malignant  glioma  in  three  respects.  First,  it  will  evaluate  the  role  of 
adjuvant  chemotherapy  in  a  recognizible  subset  of  patients  with  malignant  glioma,  those  with 
oligodendroglial  differentiation.  Second,  the  RT  treatment  volume  will  be  based  on  a  postoperative 
pre-randomization  MR  image,  rather  than  the  customary  preoperative  diagnostic  CT  or  MR.  Third, 
in  the  experimental  arm  of  this  study,  chemotherapy  will  be  given  prior  to  RT.  Patients  whose 
tumors  progress  on  chemotherapy  will  proceed  to  RT  immediately.  There  will  be  a  central 
pathology  review  prior  to  randomization,  central  radiology  review  to  assess  response  to  PCV  and  to 
substantiate  tumor  progression,  and  a  quality  of  life  assessment  (QLA)  to  document  the  acute  and 
chronic  toxicities  of  chemotherapy  and  radiation  including  effects  on  cognitive  function.  Surgery 
and  radiotherapy  ±  PCV  may  adversely  affect  a  patient's  physical  and  emotional  functioning.  The 
Karnofsky  performance  status  (KPS)  will  measure  physical  well-being.  To  complement  KPS,  the 
Mini-Mental  Status  exam  (MMSE)  will  be  administered  to  patients  to  assess  cognitive  ability. 
Assessment  of  differences  in  quantitative  survival  will  be  performed  between  the  two  therapeutic 
regimens  supplemented  with  qualitative  survival  by  the  assessment  of  KPS,  MMSE,  and  QLA. 

Progress:  This  protocol  closed  to  patient  entry  in  March  2002,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  during  FY06. 


133 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  94163  Status:  Ongoing 

Title:  SWOG  9410  (INT  0148):  Doxorubicin  Dose  Escalation,  With  or  Without  Taxol,  As  Part  of 

the  CA  Adjuvant  Chemotherapy  Regimen  for  Node  Positive  Breast  Cancer:  A  Phase  III 

Intergroup  Study 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/20/1995  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  8/29/2006 

Study  Objective:  To  determine  (1)  whether  dose  escalation  of  doxorubicin  used  as  an  adjuvant 
with  cyclophosphamide  in  patients  with  early  breast  cancer  will  increase  disease  free  and  overall 
survival;  (2)  whether  the  use  of  Taxol  as  a  single  agent  after  the  completion  of  4  cycles  of 
cyclophosphamide  and  doxorubicin  in  combination  will  further  improve  disease-free  and  overall 
survival  compared  to  cyclophosphamide  and  doxorubicin  alone;  (3)  if  Taxol  following  standard  dose 
cyclophosphamide  and  doxorubicin  will  be  as  effective  or  more  effective  than  high  dose 
cyclophosphamide  and  doxorubicin  without  Taxol;  (4)  to  access  the  toxicity  of  the  different  doses  of 
cyclophosphamide  and  doxorubicin  with  and  without  Taxol  using  the  end  point  of  life  threatening 
or  lethal  toxicity;  (5)  whether  the  longer  duration  of  chemotherapy  treatment  for  patients 
randomized  to  receive  Taxol  is  associated  with  a  reduction  in  local  recurrence  in  patients  with 
lumpectomy  and  radiotherapy. 

Technical  Approach:  Women  with  breast  cancer,  who  have  been  treated  with  either  mastectomy 
or  segmentectomy  will  receive  adjuvant  chemotherapy.  All  patients  will  receive  4  courses  of 
cyclophosphamide  and  doxorubicin  (21  day  cycle),  but  the  doxorubicin  dose  will  vary  depending 
upon  the  randomization.  Patients  randomized  to  high  dose  doxorubicin  will  also  receive  G-CSF  & 
ciprofloxacin.  Some  women  will  be  randomized  to  receive  Taxol  after  4  cycles  of  AC  chemotherapy 
is  completed.  They  will  receive  taxol  day  1  of  a  21  day  cycle  for  4  cycles.  Women  with  ER  positive 
tumors  will  be  given  tamoxifen  for  5  years. 

Progress:  This  protocol  closed  to  patient  entry  in  April  1997,  with  nine  patients  enrolled.  Four 
patients  died  due  to  disease  progression  and  four  patients  remain  disease  free  and  continued  to  be 
followed  during  FY06. 


134 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  96095  Status:  Ongoing 

Title:  SWOG  9514:  Phase  III  Double-Blind,  Placebo-Controlled,  Prospective  Randomized 

Comparison  of  Adjuvant  Therapy  with  Tamoxifen  vs.  Tamoxifen  &  Fenretinide  in 

Postmenopausal  Women  with  Involved  Axillary  Lymph  Nodes  and  Positive  Receptors, 

Intergroup 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/21/1996  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  3/15/2006 

Study  Objective:  1)  To  compare  disease-free  survival  and  overall  survival  of  postmenopausal 
primary  breast  cancer  patients  with  involved  axillary  nodes  and  positive  estrogen  or  progesterone 
receptors  who  are  treated  with  standard  adjuvant  tamoxifen  vs.  tamoxifen  and  fenretinide;  2)  to 
gain  wider  experience  and  toxicity  information  on  the  combination  of  tamoxifen  and  fenretinide; 
and  3)  to  obtain  tumor  tissue  from  these  patients  for  future  biologic  studies  of  relevance  to  this 
patient  population. 

Technical  Approach:  The  present  standard  of  therapy  for  node  positive  and  ER  positive  post 
menopausal  women  is  Tamoxifen  alone.  There  are  some  studies  that  suggest  that  the  addition  of 
adjuvant  chemotherapy  combined  with  hormonal  therapy  will  prolong  relapse  free  and  overall 
survival.  However,  not  all  patients,  especially  in  the  over  65  year  old  age  group,  can  tolerate  or 
want  the  significant  side  effects  of  chemotherapy.  Thus,  a  less  toxic  regimen  is  needed.  This  study 
attempts  to  use  a  chemoprophylactic  approach  along  with  the  standard  Tamoxifen  treatment  for 
this  group  of  patients.  This  new  retinoid  has  shown  some  effectiveness  in  Phase  I  and  II  studies 
when  given  in  combination  with  Tamoxifen  to  untreated  metastatic  breast  cancer  patients.  This 
study  will  test  its  use  in  a  Phase  III  randomized,  prospective,  placebo-controlled  trial.  The  side 
effects  seem  to  be  fairly  minimal  except  for  night  blindness  which  will  be  closely  monitored  during 
this  trial. 

Progress:  This  protocol  closed  to  patient  entry  in  November  1999,  with  four  patients  enrolled  who 
remain  disease  free  and  continue  to  be  followed  at  MAMC  during  FY06. 


135 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  96118  Status:  Ongoing 

Title:  SWOG  9515:  Phase  III  Intergroup  Trial  of  Surgery  Followed  by  (1)  Radiotherapy  vs.  (2) 

Radiochemotherapy  for  Resectable  High  Risk  Squamous  Cell  Carcinoma  of  the  Head  and  Neck 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/20/1996  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  4/10/2006 

Study  Objective:  1)  To  determine  the  efficacy  of  concurrent  cisplatinum  and  radiotherapy 
following  surgical  resection  in  patients  who  have  advanced  squamous  cell  carcinoma  of  the  head 
and  neck  region;  2)  to  test  whether  the  use  of  concurrent  chemoradiotherapy  following  surgery 
increases  locoregional  control  rates;  3)  to  determine  if  the  patterns  of  first  failure  are  changed  by 
the  use  of  concurrent  chemotherapy;  4)  to  determine  whether  the  use  of  concurrent 
chemoradiotherapy  prolongs  disease-free  survival  and/or  overall  survival;  and  5)  to  compare  the 
toxicity  of  concurrent  chemoradiotherapy  versus  radiation  alone  in  the  postoperative  setting. 

Technical  Approach:  In  head  and  neck  squamous  cell  carcinomas  with  high  risk  features,  there 
is  a  20  to  50  percent  recurrence  rate  after  surgical  resection.  These  high  risk  features  include 
greater  than  2  lymph  nodes  positive,  extracapsular  extension  of  cancer  in  lymph  nodes,  and 
positive  resection  margins.  In  the  past,  patients  with  these  high  risk  features  had  received 
radiation  therapy  for  local  control.  There  is  evidence,  however,  that  the  addition  of  cisplatinum 
with  concurrent  radiation  therapy  may  help  in  local  control.  This  data  comes  from  in  vitro  as  well 
as  in  vivo  data  showing  cisplatinum  may  be  a  radiation  sensitizer  that  may  have  synergistic  local 
effects  on  malignancies.  The  study  is  a  Phase  III  randomized  study  that  will  compare  standard 
radiation  therapy  against  concurrent  cisplatinum  and  radiation  therapy  for  resected  squamous  cell 
carcinoma  of  the  head  and  neck.  The  added  toxicities  of  neuropathy,  nausea  and  emesis,  renal 
failure,  and  bone  marrow  suppression  are  tolerable  and  can  be  prevented  with  medical  measures. 

It  is  hoped  that  local  recurrence  will  be  reduced  with  this  approach  with  minimal  added  toxicity. 

Progress:  This  protocol  closed  to  patient  entry  in  May  2000,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


136 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  98112  Status:  Ongoing 

Title:  SWOG  C9581:  Phase  III  Randomized  Study  of  Adjuvant  Immunotherapy  with  Monoclonal 

Antibody  17-lA  Versus  No  Adjuvant  Therapy  Following  Resection  for  Stage  II  (Modified  Astler- 

Coller  B2)  Adenocarcinoma 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/20/1998  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  8/14/2006 

Study  Objective:  (1)  To  determine  whether  adjuvant  treatment  with  MoAb  17-lA  will  improve 
the  probability  of  overall  and  disease-free  survival,  and  increase  disease-free  intervals  in  patients 
who  have  undergone  resection  of  a  Stage  II  (pT3NO  or  pT4bNO)  colon  cancer,  (2)  to  evaluate  a 
panel  of  prognostic  markers,  in  order  to  correlate  these  measures  with  survival  and  recurrence 
after  adjuvant  therapy  in  patients  who  have  undergone  resection  of  a  Stage  II  (pT3NO  or  pT4bNO) 
colon  cancer.  The  specific  aims  of  the  companion  study  will  be:  (a)  to  determine  whether 
alterations  in  the  expression  of  cell  cycle  related  genes  (thymidylate  synthase,  p53,  and  the  cyclin- 
dependent  kinase  inhibitors  p21  and  p27)  predict  the  risk  of  survival  and  recurrence  in  this 
patient  population,  (b)  to  determine  whether  alterations  in  markers  of  metastatic  potential- 
expression  of  DCC  and  measures  of  tumor  angiogenesis  (micro vascular  density  and  vascular 
endothelial  growth  factor  expressionj-predict  the  risk  of  survival  and  recurrence  in  this  patient 
population,  (c)  to  determine  whether  a  marker  of  cellular  differentiation-sucrase  isomaltase- 
predicts  the  risk  of  survival  and  recurrence  in  this  patient  population,  and  (d)  to  determine 
whether  interactions  among  these  tumor  markers  identify  subsets  of  patients  with  significantly 
altered  outcome. 

Technical  Approach:  Subjects  will  be  randomized  and  assigned  to  one  of  two  treatment  groups 
following  standard  surgical  removal  of  their  tumor.  Group  1  will  receive  standard  care  which  is 
surgery  with  no  additional  therapy  after  the  tumor  has  been  removed.  Subjects  will  continue  with 
routine  check-ups,  doctor  visits  and  test.  Group  2  will  receive  five  antibody  treatments  using  MoAb 
17-lA.  Subjects  will  receive  the  drug  by  as  an  intravenous  infusion  over  a  2-hour  time  period  once 
each  28  days.  This  2-hour  infusion  will  be  repeated  every  4  weeks  for  a  total  of  5  treatments. 
During  treatment,  various  blood  tests  and  x-rays  will  be  used  to  determine  whether  the  disease 
has  returned.  With  subject's  approval,  tissue,  body  fluids,  and  other  specimens  obtained  during  the 
normal  course  of  treatment  will  be  forwarded  to  a  special  research  laboratory  for  storage  and 
scientific  testing.  Subjects  will  also  be  asked  to  complete  a  background  information  form  to  help 
define  groups  of  patient  being  treated. 

Progress:  This  protocol  closed  to  patient  entry  in  May  2002,  with  one  patient  enrolled  in  FY98 
who  continued  to  be  followed  at  MAMC  during  FY06. 


137 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  99014  Status:  Ongoing 

Title:  SWOG  C9741:  A  Randomized  Phase  III  Trial  of  Sequential  Chemotherapy  Using 
Doxorubicin,  Paclitaxel,  and  Cyclophosphamide,  or  Concurrent  Doxorubicin  and 
Cyclophosphamide  Followed  by  Paclitaxel  at  14  or  21  Day  Intervals  in  Women  with  Node 
Positive  Stage  II/IIIA  Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/26/1999  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  11/21/2006 

Study  Objective:  (1)  To  compare  sequential  chemotherapy  with  Doxorubicin,  Paclitaxel,  and 
Cyclophosphamide  to  combined  Doxorubicin  and  Cyclophosphamide  followed  by  Paclitaxel  for 
disease-free  and  overall  survival,  (2)  to  determine  whether  increasing  the  dose  density  of  adjuvant 
chemotherapy  (decreasing  the  interval  between  chemotherapy  courses  from  21  to  14  days)  will 
improve  disease-free  and  overall  survival,  and  (3)  to  compare  the  toxicity  for  patients  treated  with 
sequential  Doxorubicin,  Paclitaxel,  and  Cyclophosphamide  with  toxicity  for  patients  with 
concurrent  Doxorubicin  plus  Cyclophosphamide  followed  by  Paclitaxel  at  14  and  21  day  intervals. 

Technical  Approach:  This  is  a  randomized  comparison  of  several  aggressive  combination 
chemotherapy  regimens  in  the  treatment  of  high-risk  breast  cancer  due  to  positive  lymph  nodes.  It 
compares  the  current  standard  of  care  for  node  positive  breast  cancer  with  several  more  aggressive 
variations.  All  patients  will  receive  the  same  number  of  drugs  and  the  same  amount  of  drugs,  but 
the  order  in  which  the  drugs  are  given  and  the  time  between  treatments  (2  weeks  versus  3  weeks) 
will  be  different.  Arm  1,  patients  will  receive  Doxorubicin  once  every  3  weeks  x  4  total  doses 
followed  by  Paclitaxel  once  every  3  weeks  x  4  total  doses  followed  by  Cyclophosphamide  once  every 

3  weeks  x  4  total  doses.  Arm  2,  patient  will  receive  Doxorubicin  once  every  2  weeks  x  4  total  doses 
followed  by  Paclitaxel  once  every  2  weeks  x  4  total  doses  followed  by  Cyclophosphamide  once  every 
2  weeks  x  4  total  doses.  Arm  3,  patients  will  receive  Doxorubicin  and  Cyclophosphamide  once 
every  3  weeks  x  4  total  doses  followed  by  Paclitaxel  once  every  3  weeks  x  4  total  doses.  Arm  4, 
patients  will  receive  patients  will  receive  Doxorubicin  and  Cyclophosphamide  once  every  2  weeks  x 

4  total  doses  followed  by  Paclitaxel  once  every  2  weeks  x  4  total  doses.  G-CSF  and  Ciprofloxacin 
will  be  given  concurrent  with  each  arm  to  help  ameliorate  side  effects  of  the  treatments. 

Progress:  This  protocol  closed  to  patient  entry  in  March  1999,  with  three  patients  enrolled.  One 
patient  is  deceased  and  two  patients  remain  disease  free  and  continued  to  be  followed  at  MAMC 
during  FY06. 


138 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200036  Status:  Ongoing 

Title:  SWOG  E1199:  A  Phase  III  Study  of  Doxorubicin-Cyclophosphamide  Therapy  Followed  by 
Paclitaxel  or  Docetaxel  Given  Weekly  or  Every  3  Weeks  in  Patients  with  Axillary  Node-Positive 
Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/29/2000  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  1/4/2006 

Study  Objective:  (1)  To  determine  whether  docetaxel  improves  disease-free  survival  and  overall 
survival  when  compared  to  paclitaxel  following  4  cycles  of  doxorubicin-cyclophosphamide  therapy 
(2)  To  determine  whether  weekly  administration  of  taxanes  (paclitaxel  or  docetaxel)  for  12  weeks 
improves  disease-free  survival  and  overall  survival  when  compared  with  the  conventional  (every  3 
weeks)  schedule  for  4  cycles  following  4  cycles  of  doxorubicin-cyclophosphamide  therapy  (3)  To 
compare  the  toxicity  of  docetaxel  given  weekly  for  12  weeks  to  that  of  paclitaxel  given  every  3 
weeks  for  4  cycles  (4)  To  compare  the  toxicity  of  paclitaxel  given  weekly  for  12  weeks  for  4  cycles 
to  that  of  docetaxel  given  every  3  weeks  for  4  cycles  (5)  To  compare  the  toxicity  of  paclitaxel  given 
every  3  weeks  for  4  cycles  to  that  of  docetaxel  given  every  3  weeks  for  4  cycles  and  (6)  To  compare 
the  toxicity  of  paclitaxel  given  weekly  for  12  weeks  to  that  of  docetaxel  given  weekly  for  12  weeks. 

Technical  Approach:  This  study  compares  aggressive  chemotherapy  schedules  to  standard  of 
care  for  high  risk  node  positive  breast  cancer.  Eligible  patients  will  be  randomized  into  one  of  four 
treatment  arms:  Arm  A,  12  weeks  of  Adriamycin  and  Cytoxan  followed  by  12  weeks  of  Taxol  (the 
standard  treatment);  Arm  B,  12  weeks  of  Adriamycin  and  Cytoxan  followed  by  12  weeks  of  Taxol 
(lower  dose  than  standard);  Arm  C,  12  weeks  of  Adriamycin  and  Cytoxan  followed  by  12  weeks  of 
Taxotere  (medium  dose);  and  Arm  D,  12  weeks  of  Adriamycin  and  Cytoxan  followed  by  12  weeks  of 
Taxotere  (low  dose). 

All  Arms  will  receive  Adriamycin  and  cyclophosphamide,  IV  once  every  3  weeks  for  4  cycles.  Then 
Arm  A  will  receive  Taxol,  IV  once  every  3  weeks  for  4  treatments.  Arm  B  will  receive  Taxol  IV  once 
a  week  for  12  weeks  of  treatment.  Arm  C  will  receive  Taxotere  IV  once  every  3  weeks  for  4 
treatments.  Arm  D  will  receive  Taxotere  once  a  week  for  12  weeks  of  treatment. 

Progress:  This  protocol  closed  to  patient  entry  in  January  2002,  with  fourteen  patients  enrolled. 
One  patient  died  and  thirteen  remain  disease  free  and  continued  to  be  followed  at  MAMC  during 
FY06. 


139 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  99071  Status:  Ongoing 

Title:  SWOG  E2197:  Phase  III  Study  of  Adriamycin/Taxotere  vs.  Adriamycin/Cytoxan  for  the 
Adjuvant  Treatment  of  Node  Positive  or  High  Risk  Node  Negative  Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/20/1999  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  4/20/2006 

Study  Objective:  To  determine  whether  Adriamycin/Taxotere  will  improve  disease-free  survival 
and  overall  survival  when  compared  to  Adriamycin/Cytoxan  in  lymph  node  positive  (1-3  positive 
nodes)  and  high  risk  lymph  node  negative  breast  cancer.  To  compare  toxicity  of 
Adriamycin/Taxotere  to  Adriamycin/Cytoxan. 

Technical  Approach:  This  is  multi-site  study  with  randomization  to  one  of  two  arms: 
Adriamycin/Taxotere  (AT)  or  Adriamycin/Cytoxan  (AC).  The  dosages  for  the  AT  group:  Adriamycin 
60  mg/M2  IV  and  Taxotere  60  mg/M2  IV  over  1  hour  infusion  every  3  weeks  x  4  cycles.  Cipro  500 
mg  PO  b.i.d.  starting  Day  8  and  continuing  x  10  days.  If  a  patient  is  allergic  to  Cipro,  an 
alternative  broad  spectrum  antibiotic  may  be  used.  Decadron  8  mg  PO  b.i.d.,  beginning  one  day 
prior  to  treatment  with  Taxotere  and  continued  for  two  additional  days;  repeat  q  3  weeks  x  4 
cycles.  The  dosages  for  the  AC  group:  Adriamycin  60  mg/m2  IV  and  Cytoxan  600  mg/ml  IV.  Every 
3  weeks  x  4  cycles.  In  both  groups,  post-menopausal  patients  who  are  ER  and/or  PR  positive  will 
receive  Tamoxifen  20  mg  PO  daily  x  5  years  at  the  completion  of  chemotherapy.  G-CSF:  Patients 
who  have  an  episode  of  febrile  neutropenia  should  be  placed  on  G-CSF  according  to  ASCO 
Guidelines.  Patients  who  have  febrile  neutropenia  after  a  subsequent  dose  of  chemotherapy  in 
spite  of  G-CSF  should  have  the  chemotherapy  doses  lowered  by  25%. 

Progress:  This  protocol  closed  to  patient  entry  in  January  2000,  with  two  patients  enrolled  who 
continued  to  be  followed  at  MAMC  during  FY06. 


140 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204066  Status:  Ongoing 

Title:  SWOG  E2496  Randomized  Phase  III  Trial  of  ABVD  Versus  Stanford  V  +/-  Radiation 
Therapy  in  Locally  Extensive  and  Advanced  Stage  Hodgkin's  Disease  With  0-2  Risk  Factors 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
John  B.  Halligan,  MC;  LTC  William  B.  Reece,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/17/2004  -  Apr  2009  SWOG  via  Henry  M.  Jackson  Foundation  5/23/2006 

Study  Objective:  (1)  To  compare  the  failure-free  survival  in  patients  with  locally  extensive  and 
advanced  stage  Hodgkin's  \disease  d(HD)  treated  with  standard  ABVD  chemotherapy  + 
radiotherapy  versus  patients  given  Stanford  V  chemotherapy  +radiotherapy.  (2)  To  assess  overall 
survival  and  freedom  from  progression  in  these  patients  at  5  and  10  years.  (3)  To  assess  secondary 
endpoints:  pulmonary  function,  incidence  of  second  cancers,  reproductive  function  (at  baseline  and 
at  5  years)  and  deaths  from  causes  other  than  Hodgkin's  disease. 

Technical  Approach:  SWOG  E2496  is  a  national  intergroup  randomized  Phase  III  trial  of  two 
treatment  regimens  for  the  treatment  of  locally  extensive  and  advanced  stage  Hodgkin's  disease. 
Subjects  with  bulky  disease  will  receive  radiation  therapy  in  addition  to  chemotherapy  in  the 
control  ABVD  treatment  Arm  and  subjects  with  lymphoma  masses  >  5  cm  will  receive  radiation 
therapy  on  the  Stanford  V  Arm.  The  primary  endpoint  of  the  trial  is  failure  free  survival. 
Laboratory  endpoints  include  relative  risk  of  death  and  treatment  failure  in  subjects  with  EBV- 
positive  disease,  the  concordance  between  three  different  EBV  detection  techniques,  and  the 
relationship  of  EBV  viral  DNA  clearance  for  the  two  treatment  arms.  Laboratory  studies  will  also 
investigate  the  relationship  between  T-cell  response  and  EBV  status  and  the  time  course  of  the  T- 
cell  response.  This  is  a  national  intergroup  study  expected  to  accrue  204  subjects  per  year  for  a 
total  of  850  subjects.  At  MAMC  2  subjects  per  year  are  expected  to  enroll.  Data  and  statistical 
analysis  will  be  conducted  by  the  sponsoring  study  group,  ECOG  (Eastern  Cooperative  Oncology 
Group)  with  planned  interim  analyses  at  33%  and  67%  of  the  number  of  anticipated  treatment 
failures.  It  is  expected  that  3  years  of  follow-up  will  be  required  after  complete  accrual. 

Progress:  This  protocol  closed  to  enrollment  in  April  2006;  four  patients  enrolled  at  MAMC.  Three 
patients  remain  in  follow-up  and  one  transferred  to  another  facility. 


141 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200040  Status:  Ongoing 

Title:  SWOG  E4494:  Phase  III  Trial  of  CHOP  versus  CHOP  and  Chimeric  Anti-CD20 

Monoclonal  Antibody  (IDEC-C2B8)  in  Older  Patients  with  Diffuse  Mixed,  Diffuse  Large  Cell  and 

Immunoblastic  Large  Cell  Histology  Non-Hodgkin's  Lymphoma 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/25/2000  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  1/4/2006 

Study  Objective:  (1)  To  compare  CHOP  treatment  with  or  without  chimeric  anti-CD20 
monoclonal  antibody  (IDEC-C2B8)  in  elderly  patients  with  diffuse  mixed,  diffuse  large  cell,  and 
immunoblastic  large  cell  non-Hodgkin's  lymphoma  of  B  lineage  with  respect  to  response  rate,  the 
time  to  treatment  failure,  toxicity  and  survival,  (2)  To  compare  IDEC-C2B8  monoclonal  antibody 
as  maintenance  therapy  to  observation  alone  after  CHOP  chemotherapy  with  respect  to  time  to 
treatment  failure,  duration  of  response,  toxicity  and  survival  after  an  initial  response  to  induction 
therapy  of  CHOP  +  IDEC-C2B8,  and  (3)  To  determine  if  maintenance  therapy  with  IDEC-C2B8 
results  in  the  conversion  of  any  partial  responses  to  a  complete  response. 

Technical  Approach:  This  study  adds  a  new  drug,  chimeric  anti-CD20  monoclonal  antibody,  to 
the  standard  treatment  (cyclophosphamide,  doxorubicin,  vincristine  and  prednisone,  CHOP)  of 
Non-Hodgkin's  Lymphoma.  Patients  eligible  for  this  study  will  be  randomized  to  receive  or  not  to 
receive  IDEC-C2B8  (anti-CD20)  in  conjunction  with  chemotherapy.  Treatment  Arm  A,  CHOP  plus 
Anti-CD20  will  receive  the  study  drug  IV  over  6  to  12  hours  on  Days  7  and  3  before  the  first 
treatment  cycle  of  CHOP.  Anti-CD20  will  also  be  given  48  hours  prior  to  cycles  3,  5  and  7  of  CHOP 
Treatment  Arm  B  will  receive  CHOP  for  a  minimum  of  6  or  a  maximum  of  8  cycles.  Restaging  of 
disease  after  4  cycles  and  again  after  6  cycles  will  be  done  to  determine  response  and  eligibility  to 
be  randomized  to  Maintenance  Treatment  Arms  C  &  D.  Arm  C  will  continue  to  receive  Anti-CD20 
IV,  four  weekly  doses  every  6  months  for  2  years.  Arm  D  will  be  the  observation  group. 

Progress:  This  protocol  closed  to  patient  entry  in  May  2001,  with  two  patients  enrolled.  One 
patient  died  and  the  other  patient  continued  to  be  followed  at  MAMC  during  FY06. 


142 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202010  Status:  Ongoing 

Title:  SWOG  E5597:  Phase  III  Chemoprevention  Trial  of  Selenium  Supplementation  in  Persons 
with  Resected  Stage  I  Non-Small  Cell  Lung  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/23/2001  -  Oct  2005  SWOG  via  Henry  M.  Jackson  Foundation  8/22/2006 

Study  Objective:  (1)  To  evaluate  the  efficacy  of  selenium  supplementation  in  reducing  the 
incidence  of  second  primary  lung  tumors  in  patients  who  have  been  treated  for  Stage  I  non-small 
cell  cancer  with  complete  surgical  resection,  (2)  to  evaluate  the  qualitative  and  quantitative 
toxicity  of  a  selenium  supplementation  in  a  daily  administration  schedule  and  (3)  to  compare  the 
incidence  of  specific  cancers  and  mortality  from  cancer  as  well  as  overall  survival  of  patients 
treated  with  selenium  supplementation  versus  patients  treated  with  placebo. 

Technical  Approach:  Selenium  chemo-prevention  may  improve  upon  patients  with  high  risk  of 
second  lung  primaries  as  well  other  aero  digestive  tract  tumors. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  two  patients  enrolled  at  MAMC.  Both 
patients  remain  on  active  study  treatment. 


143 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202012  Status:  Ongoing 

Title:  SWOG  G0182:  A  Phase  III  Randomized  Trial  of  Paclitaxel  and  Carboplatin  Versus  Triplet 
or  Sequential  Doublet  Combinations  in  Patients  with  Epithelial  Ovarian  or  Primary  Peritoneal 
Carcinoma 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Jane  Shen-Gunther,  MC;  LTC  Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/23/2001  -  Nov  2004  SWOG  via  Henry  M.  Jackson  Foundation  9/29/2006 

Study  Objective:  (1)  To  compare  the  efficacy  of  each  experimental  arm  with  the  control  arm 
(paclitaxel  and  Carboplatin).  Efficacy  will  be  determined  through  analysis  of  overall  survival  and 
progression-free  survival,  (2)  To  compare  the  response  rate  in  patients  with  measurable  disease, 
toxicities  and  complications  of  each  treatment  regimen  and  to  describe  dose-intensity  and 
cumulative  dose  delivery  for  each  regimen  and  (3)  To  extend  the  accrual  into  a  study  initiated  with 
GOG  Protocol  #0172  which  will  assess  whether  inactivated  BRCAl  and  /or  BRCA2  is  a  prognostic 
factor  for  clinical  outcome. 

Technical  Approach:  This  study  is  designed  to  compare  the  effectiveness  and  side  effects  of 
several  chemotherapy  combinations  (Paclitaxel,  Carboplatin,  Gemcitabine,  Topotecan,  Doxil 
[Liposomal  Doxorubicin])  which  are  known  to  be  effective  in  women  with  ovarian  or  primary 
peritoneal  cancer.  This  study  will  enroll  adult  females  with  histologic  diagnosis  of  primary 
peritoneal  carcinoma  or  epithelial  ovarian  carcinoma,  Stage  III  or  IV,  with  either  optimal  or 
suboptimal  residual  disease  following  initial  surgery. 

Progress:  This  study  closed  to  patient  entry  in  September  2004,  with  eight  patients  enrolled. 
Three  patients  continued  to  be  followed  at  MAMC  during  FY06. 


144 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  97070  Status:  Ongoing 

Title:  SWOG  JBR.10  (NCIC  CTG  BR.10):  A  Phase  III  Prospective  Randomized  Study  of 

Adjuvant  Chemotherapy  with  Vinorelbine  and  Cisplatin  in  Completely  Resected  Non-small  Cell 

Lung  Cancer  with  Companion  Tumour 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

3/21/1997  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  2/22/2006 

Study  Objective:  1)  To  compare  the  duration  of  overall  survival  (OS)  between  completely  rejected 
patients  with  T2  NO,  T1-2N1  non-small  cell  lung  cancer  (NSCLC)  who  have  received  either 
adjuvant  chemotherapy  with  vinorelbine  and  cisplatin  or  observation  alone.  2)  To  determine 
disease-free  survival.  3)  To  confirm  the  prognostic  significance  of  ras  mutations  when  present  in 
the  primary  tumor.  4)  To  provide  a  comprehensive  tumor  bank  linked  to  a  clinical  data  base  for  the 
further  study  of  molecular  markers  in  rejected  NSCLC.  5)  To  measure  and  compare  health  related 
quality  of  life  in  both  treatment  arms  throughout  the  study  period.  6)  To  evaluate  toxicity  related 
to  chemotherapy. 

Technical  Approach:  The  role  of  adjuvant  chemotherapy  in  Non-small  cell  lung  cancer  is 
controversial.  Most  clinical  trials  have  shown  no  benefit  to  adjuvant  chemotherapy.  In  the  early 
80's  the  lung  cancer  study  group  showed  some  benefit  with  combination  chemotherapy  in  terms  of 
survival,  however,  the  control  arm  was  not  a  strict  observational  arm  and  contained  a  "biological 
response  modifier"  in  it.  Thus  with  recent  improved  survival  in  Stage  IV  lung  cancer  shown 
compared  to  observation,  it  is  assumed  that  using  platinum  based  therapies  may  enhance  survival 
in  patients  that  have  completely  rejected  non-small  cell  lung  cancer.  In  patients  with  rejected 
Stage  I,  II,  and  III  Non-small  cell  lung  cancer  it  is  known  that  the  long  term  survival  rates  are  50 
to  60%,  30  to  50%,  and  19  to  49%  respectively.  It  is  thus  the  aim  of  this  study  to  assess  whether 
adjuvant  therapy  with  Cisplatin  and  Vinorelbine  will  improve  survival  and  relapse  free  survival 
compared  to  observation.  In  addition  to  the  above  study,  tissue  samples  will  be  sent  to  the 
University  of  Washington  for  evaluation  of  Ras  mutations  to  assess  its  prognostic  importance. 

Progress:  This  protocol  closed  to  patient  entry  in  April  2001,  with  two  patients  enrolled  who 
remain  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06. 


145 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  99040  Status:  Ongoing 

Title:  SWOG  JMA.17:  A  Phase  III  Randomized  Double-Blinded  Study  of  Letrozole  Versus 
Placebo  in  Women  with  Primary  Breast  Cancer  Completing  Five  or  More  Years  of  Adjuvant 
Tamoxifen 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/23/1999  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  1/24/2006 

Study  Objective:  Primary:  To  determine  the  disease-free  survival  and  overall  survival  (all  cause 
mortality)  for  women  who  have  previously  received  >=  5  years  of  adjuvant  Tamoxifen,  randomized 
to  receive  wither  Letrozole  2.5  mg  daily  or  placebo  daily  for  5  years. 

Secondary:  To  evaluate  the  incidence  of  contralateral  breast  cancer.  To  evaluate  the  long  term 
clinical  and  laboratory  safety  of  Letrozole  with  special  attention  to:  lipid  profile  as  assessed  by 
blood  sampling  (in  a  limited  number  of  centers),  cardiovascular  morbidity  and  mortality  (i.e. 
significant  coronary  heart  disease,  which  includes  myocardial  infarctions  and  angina  requiring 
percutaneous  transluminal  coronary  angioplasty  or  coronary  artery  bypass  graft,  fatal  and 
nonfatal  strokes  and  all  vascular  deaths)  as  assessed  by  reported  toxicity,  the  incidence  of  all  bone 
fractures  (with  particular  emphasis  on  hip  and  wrist  fractures  as  indicators  of  osteoporosis)  as 
assessed  by  reported  toxicity,  changes  in  bone  density  (in  a  limited  number  of  centers),  common 
toxicities  as  assessed  by  reported  toxicity. 

Third:  To  evaluate  overall  quality  of  life. 

Technical  Approach:  This  is  a  multi-centre,  double-blind,  placebo-controlled  parallel  randomized 
trial  of  the  NCIC  Clinical  Trials  Group,  supported  by  Novartis.  Patients  will  be  stratified  by: 
receptor  status  at  diagnosis  (positive,  unknown),  lymph  node  status  at  diagnosis  (negative, 
positive,  unknown),  and  a  prior  adjuvant  chemotherapy  (yes,  no).  Patients  will  be  centrally 
randomized  to  receive  one  of  the  following  treatments:  Arm  1  (letrozole):  2.5  mg  po  daily  x  5  years 
or  Arm  2  (Placebo):  po  daily  x  5  years. 

Progress:  This  protocol  closed  to  patient  entry  in  December  2005,  with  thirteen  patients  enrolled; 
two  patients  continue  on  Letrozole.  One  patient  is  deceased;  twelve  patients  continued  to  be 
followed  at  MAMC  during  FY06. 


146 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200120  Status:  Ongoing 

Title:  SWOG  N9831:  Phase  III  Trial  of  Doxorubicin  and  Cyclophosphamide  (AC)  Followed  by 

Weekly  Paclitaxel  With  or  Without  Trastuzumab  as  Adjuvant  Treatment  for  Women  with  HER-2 

Over-expressing  or  Amplified  Node  Positive  or  High-Risk  Node  Negative  Breast  Cancer  (an 

Intergroup  Study) 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 

Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/22/2000  -  Dec  2005  SWOG  via  Henry  M.  Jackson  Foundation  7/18/2006 

Study  Objective:  (1)  To  compare  the  combination  AC  followed  by  weekly  paclitaxel  with  the 
sequential  schedule  of  the  combination  of  AC,  weekly  paclitaxel,  and  trastuzumab  in  terms  of 
disease-free  survival  (DFS).  (2)  To  compare  the  combination  of  AC  followed  by  weekly  paclitaxel 
with  the  combination  of  AC  followed  by  the  combination  of  weekly  paclitaxel  and  trastuzumab  in 
terms  of  DFS.  (3)  To  compare  the  sequential  schedule  of  AC,  weekly  paclitaxel,  and  trastuzumab 
with  the  combination  of  weekly  paclitaxel  and  trastuzumab  in  terms  of  DFS.  (4)  To  compare  the 
cardiotoxicities  of  (a)  AC  followed  by  weekly  paclitaxel,  (b)  AC  followed  by  weekly  paclitaxel 
followed  by  weekly  trastuzumab,  and  (c)  AC  followed  by  weekly  paclitaxel  and  trastuzumab 
followed  by  weekly  trastuzumab. 

Technical  Approach:  Subjects  will  be  randomly  assigned  to  one  of  three  arms:  Arm  A  - 
Adriamycin  and  Cytoxan  (AC)  by  vein  over  about  30  minutes  one  day  every  three  weeks  for  a  total 
of  four  treatments.  After  all  treatment  with  AC  is  done  (about  week  12),  Taxol  by  vein  over  1  hour 
one  day  every  week  for  a  total  of  12  treatments.  Total  length  of  treatment  will  be  about  six 
months.  Arm  B  -  Subjects  will  be  given  Adriamycin  and  Cytoxan  (AC)  by  vein  over  about  30 
minutes  one  day  every  three  weeks  for  a  total  of  four  treatments.  After  all  treatment  with  AC  is 
done  (about  week  12),  you  will  get  Taxol  by  vein  over  1  hour  one  day  every  week  for  a  total  of  12 
treatments.  After  all  treatment  with  Taxol  is  done  (about  week  24),  Herceptin  by  vein  one  day 
every  week  for  one  year.  The  first  dose  of  Herceptin  will  be  given  over  about  90  minutes.  Subjects 
will  be  watched  for  1  hour  after  the  first  dose  of  Herceptin.  If  they  do  well  this  first  dose,  other 
doses  will  be  given  over  about  30  minutes.  Total  length  of  treatment  will  be  about  18  months.  Arm 
C  -  Subjects  will  be  given  Adriamycin  and  Cytoxan  (AC)  by  vein  over  about  30  minutes  one  day 
every  three  weeks  for  a  total  of  four  treatments.  After  all  treatment  with  AC  is  done  (about  week 
12),  subjects  will  be  given  Taxol,  by  vein  over  1  hour,  plus  Herceptin,  by  vein  one  day  every  week, 
for  a  total  of  12  treatments.  After  all  treatment  with  Taxol  plus  Herceptin  is  done  (about  week  23), 
subjects  will  get  Herceptin  alone  one  day  every  week  for  six  months.  The  first  dose  of  Herceptin 
will  be  given  over  about  90  minutes.  You  will  be  watched  for  1  hour  after  the  first  dose  of 
Herceptin.  If  subjects  do  well  this  first  dose,  other  doses  will  be  given  over  about  30  minutes.  Total 
length  of  treatment  will  be  about  one  year. 

Regardless  of  which  treatment,  at  the  end  of  all  chemotherapy,  subject  may  also  get  Tamoxifen,  if 
estrogen  or  progesterone  receptor  positive,  for  five  years.  If  subjects  had  a  lumpectomy,  they  will 
also  get  radiation  therapy  after  chemotherapy  has  ended.  Blood  samples  will  be  taken  before  the 
start  treatment  for  research  use.  Subjects  will  be  followed  indefinitely. 

Progress:  This  protocol  closed  to  patient  entry  in  April  2005,  with  nine  patients  enrolled.  One 
patient's  death  was  unrelated  to  study  participation,  two  patients  removed  from  the  study  due  to 


147 


decreases  in  LVF,  and  the  remaining  six  patients  completed  study  treatment.  Eight  patients 
continued  to  be  followed  at  MAMC  during  FY06. 


148 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201136  Status:  Completed 

Title:  SWOG  S0009:  A  Phase  II  Evaluation  of  Neoadjuvant  Chemotherapy,  Interval  Debulking 
Followed  by  Intraperitoneal  Chemotherapy  in  Women  with  Stage  III  and  IV  Epithelial  Ovarian 
Cancer,  Fallopian  Tube  Cancer  or  Primary  Peritoneal  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC;  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/25/2001  -  Aug  2004  SWOG  via  Henry  M.  Jackson  Foundation  8/24/2005 

Study  Objective:  (1)  To  evaluate  the  overall  survival  and  progression-free  survival  in  Stage  III  or 
IV  epithelial  ovarian,  fallopian  tube  or  primary  peritoneal  carcinoma  patients  with  bulky  disease 
and/or  malignant  pleural  effusions  treated  with  neoadjuvant  intravenous  paclitaxel  and 
Carboplatin,  cytoreductive  surgery  and  intravenous/intraperitoneal  paclitaxel  and  intraperitoneal 
Carboplatin,  (2)  To  estimate  the  percent  of  patients  successfully  cytoreduced  to  optimal  disease  (<1 
cm  residual)  following  neoadjuvant  chemotherapy,  (3)  To  evaluate  the  toxicities  associated  with 
this  therapy,  and  (4)  To  explore  the  relationship  between  tumor  p53  expression,  cellular 
proliferation  rate  as  measured  by  PCNA  and  apoptotic  rate,  and  human  tumor  cloning  assay 
results  at  time  of  debulking  surgery  with  progression-free  survival  and  overall  survival  in  patients 
undergoing  cytoreductive  surgery. 

Technical  Approach:  This  protocol  evaluates  the  effectiveness  and  side  effects  of  a  treatment 
regimen  for  advanced  ovarian,  peritoneal,  and  fallopian  tube  cancers.  The  treatment  consists  of 
intravenous  chemotherapy  of  paclitaxel  and  carboplatin  (3  treatments),  followed  by  surgery, 
followed  by  a  combination  of  intravenous  paclitaxel  and  intra-peritoneal  carboplatin  and  paclitaxel 
(6  treatments). 

Progress:  This  protocol  closed  enrollment  in  February  2006,  when  accrual  goals  were  met.  No 
subjects  enrolled  at  MAMC. 


149 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201137  Status:  Ongoing 

Title:  SWOG  S0012:  A  Comparative  Randomized  Study  of  Standard  Doxorubicin  and 
Cyclophosphamide  Followed  by  Weekly  Paclitaxel  Vs.  Weekly  Doxorubicin  and  Daily  Oral 
Cyclophosphamide  Plus  G-CSF  Followed  by  Weekly  Paclitaxel  as  Neoadjuvant  Therapy  for 
Inflammatory  and  Locally  Advanced  Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/25/2001  -  Oct  2004  SWOG  via  Henry  M.  Jackson  Foundation  8/29/2006 

Study  Objective:  (1)  To  compare  the  microscopic  pathologic  response  rates  in  patients  with 
inflammatory  and  estrogen-receptor  negative  locally  advanced  breast  cancer  treated  with  weekly 
Doxorubicin  and  daily  oral  Cyclophosphamide  given  with  G-CSF  support  to  in-patients  treated 
without  "standard"  Doxorubicin  and  Cyclophosphamide  regimen  given  every  three  weeks,  (2)  To 
compare  the  toxicities  of  these  two  regimens,  (3)  To  compare  the  delivered  dose  intensity  of  these 
two  regimens,  and  (4)  To  assess  the  association  between  microscopic  pathologic  complete  response 
and  clinical  complete  response  at  the  primary  tumor  site  in  these  patients. 

Technical  Approach:  This  trial  is  designed  to  compare  two  different  treatment  regimens  for 
breast  cancer  prior  to  surgery  to  see  if  one  works  better  against  breast  cancer  than  the  other  in 
very  poor  risk  patients  who  may  benefit  from  up-front  chemotherapy.  The  standard  regimen  of 
Adriamycin  and  Cyclophosphamide  given  Day  1  every  21  days  is  compared  to  a  regimen  of 
Adriamycin  given  once  a  week  for  15  weeks  and  oral  Cyclophosphamide  daily  for  15  weeks. 
Filgrastim  and  trimethoprim  sulfa  will  also  be  given  in  this  regimen  to  protect  against  toxicity  of 
the  chemotherapy  agents  used. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  three  patients  enrolled.  One  patient  is 
deceased  and  two  continued  to  be  followed  at  MAMC  in  FY06.  No  internal  adverse  events  were 
reported  and  no  patients  received  study  treatment  in  the  past  year. 


150 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203084  Status:  Ongoing 

Title:  SWOG  S0016,  A  Phase  III  Trial  of  CHOP  +  Rituximab  vs.  CHOP  +  Iodine- 131-Labeled 
Monoclonal  Anti-Bl  Antibody  (Tositumomab)  for  Treatment  of  Newly  Diagnosed  Follicular  Non- 
Hodgkin's  Lymphomas 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/29/2003  -  Jul  2006  SWOG  via  Henry  M.  Jackson  Foundation  5/23/2006 

Study  Objective:  (1)  To  compare  progression-free  and  overall  survival  between  CHOP-Rituximab 
vs.  CHOPP+I-131  tositumomab.  (2)  To  compare  the  response  rate  between  CHOP-Rituximab  vs. 
CHOPP+I-131.(3)  To  compare  the  toxicities  of  these  two  regimens.  Also,  to  compare  the  molecular 
remission  rates  by  measuring  colonel  rearrangements  in  the  bone  marrow  at  baseline  and  at  one 
year  post-treatment. 

Technical  Approach:  This  is  a  national  trial  with  a  goal  accrual  of  500  patients  to  determine  if  a 
radioisotope  labeled  Anti-CD20  antibody  (tositumomab)  added  to  standard  CHOP  chemotherapy  is 
superior  to  a  combination  of  CHOP  plus  the  uncongealed  anti-CD20  antibody  Rituximab. 
Specifically  the  endpoints  will  include  disease  free  survival,  overall  survival,  response  rate,  rate  of 
molecular  remission  and  data  will  also  be  collected  or  the  toxicity  of  therapy.  Data  analysis  will  be 
analyzed  by  the  SWOG  Data  and  Safety  Monitoring  Committee  (DSMC).  The  power  analysis  by 
the  SWOG  DSMC  includes  a  sample  size  of  250  per  treatment  arm  will  detect  a  response  rate 
difference  of  6%  between  treatments.  Eligible  subjects  will  be  randomized  into  one  of  the  two  study 
arms.  (1)  CHOP  chemotherapy  plus  the  rituximab  antibody,  6,  21  day  treatment  cycles  or  (2) 

CHOP  chemotherapy  followed  by  the  1-131  anti-Bl  antibody,  tositumomab,  6,  21  day  treatment 
cycles.  Four  to  six  weeks  after  completion  of  chemotherapy,  subjects  will  receive  treatment  with  by 
the  1-131  anti-Bl  antibody,  tositumomab.  Also,  at  the  time  of  surgery,  tumor  tissue,  tumor  fluid, 
and  blood  will  be  collected  and  used  for  specific  experimental  molecular  tests,  called  P53,  PCNA, 
Apoptosis  and  Human  tumor  cloning  assay. 

Progress:  This  protocol  is  open  to  enrollment,  with  three  subjects  enrolled  who  completed 
treatment.  One  subject  is  deceased  due  to  progressive  disease;  two  remain  in  remission  and 
continued  on  follow-up  during  FY06. 


151 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204052  Status:  Completed 

Title:  SWOG  S0023,  A  Phase  III  Trial  of  Cisplatin/Etoposide/Radiotherapy  with  Consolidation 
Docetaxel  Followed  by  Maintenance  Therapy  with  ZD1839  or  Placebo  in  Patients  With 
Inoperable  Locally  Advanced  Stage  III  Non- Small  Cell  Lung  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
John  B.  Halligan,  MC;  LTC  William  B.  Reece,  MC;  LTC  Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/15/2004  -  Apr  2010  SWOG  via  Henry  M.  Jackson  Foundation  2/28/2006 

Study  Objective:  (1)  To  assess  whether  maintenance  therapy  with  ZD  1839  as  compared  to 
placebo  following  induction  cisplatin/etoposide/radiotherapy  plus  consolidation  docetaxel  improves 
overall  survival  and  progression-free  survival  in  patients  with  unresectable  Stage  III  non-small 
cell  lung  cancer  (NSCLC).  (2)  To  describe  the  toxicity  profile  of  long  term  administration  of 
ZD1839.  To  obtain  samples  for  correlative  studies  as  outlined  in  S9925. 

Technical  Approach:  This  study  is  an  intergroup  Phase  III  randomized,  placebo-controlled  trial 
of  a  standard  chemotherapy  /  radiation  therapy  regimen  for  inoperable  Stage  III  NSCLC  followed 
by  randomization  to  maintenance  ZD1839  (Iressa)  versus  placebo  for  5  years.  This  national  trial 
has  a  goal  accrual  of  840  over  3.5  years  or  about  240  patients  per  year  with  3  patients  per  year  at 
MAMC.  The  major  end-points  of  the  trial  are  progression-free  survival  and  overall  survival.  Data 
analysis  will  be  conducted  by  the  SWOG  monitoring  committee  with  a  planned  interim  analysis 
after  400  patients  have  been  accrued  to  see  if  pre-determined  criteria  for  early  termination  of  the 
study  have  been  met.  The  trial  is  powered  to  defect  a  33%  increase  in  median  survival  of  the 
treatment  arm. 

Progress:  This  protocol  closed  to  enrollment,  with  three  patients  enrolled;  all  deceased  due  to 
progressive  disease.  A  closure  letter  will  be  submitted  to  permanently  close  study  site. 


152 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204123  Status:  Ongoing 

Title:  SWOG  S0106,  A  Phase  III  Study  of  the  Addition  of  Gemtuzumab  Ozogamicin  (Mylotarg®) 
Induction  Therapy  Versus  Standard  Induction  With  Daunomycin  and  Cytosine  Arabinoside 
Followed  by  Consolidation  and  Subsequent  Randomization  to  Post-Consolidation  Therapy  With 
Gemtuzumab  Ozogamicin  (Mylotarg®)  or  No  Additional  Therapy  for  Patients  Under  Age  56 
With  Previously  Untreated  DeNovo  Acute  Myeloid  Leukemia  (AML) 


Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

3/21/2005  -  Jan  2012  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

9/29/2006 

Study  Objective:  (1)  To  compare  disease-free  survival  (DS)  of  patients  under  age  56  with 
previously  untreated,  de  novo,  non-M3,  MAL  who  received  gemtuzumab  ozogamicin  as  post¬ 
consolidation  therapy  versus  patients  who  received  no  post-consolidation  therapy.  (2)  To  compare 
the  complete  remission  (CR)  rate  achieved  by  the  addition  of  gemtuzumab  ozogamicin  to  standard 
induction  chemotherapy  to  that  achieved  with  standard  induction  chemotherapy  in  patients  under 
the  age  of  56  with  previously  untreated,  de  novo,  non-M-3  AML.  The  durability  of  complete 
response  will  also  be  measured.  (3)  To  estimate  the  frequency  and  severity  of  toxicities  of  the 
addition  of  gemtuzumab  ozogamicin  to  induction  therapy  and  post  consolidation  therapy.  (4)  To 
evaluate  the  prognostic  significance  of  CD33  expression  on  the  response  rate  of  those  patients  who 
receive  gemtuzumab  ozogamicin.  (5)  To  evaluate  the  prognostic  significance  of  FLT3  mutations 
prior  to  therapy,  and  of  minimal  residual  disease  in  remission  specimens  collected  before  and  after 
consolidation  therapy  and  after  post-consolidation  therapy  with  gemtuzumab  ozogamicin.  (6)  To 
evaluate  the  prognostic  significance  of  the  flow  cytometric  detection  of  minimal  residual  disease  in 
specimens  collected  before  and  after  consolidation  therapy  and  after  post-consolidation  therapy 
with  gemtuzumab  ozogamicin. 

Technical  Approach:  This  is  a  randomized  phase  III  trial  comparing  standard  induction 
chemotherapy  for  AML  with  or  without  the  anti-leukemia  monoclonal  antibody  Gemtuzumab 
ozogamicin  (Mylotarg®).  Patients  will  be  further  randomized  for  post-consolidation  treatment  with 
Gemtuzumab  ozogamicin  (Mylotarg®)  versus  no  post-consolidation  treatment.  Due  to  enhanced 
toxicity  in  older  patients,  this  trial  is  limited  to  adult  patients  less  than  age  56  at  the  time  of  study 
entry.  The  end  points  of  the  trial  are  to  compare  disease  free  survival,  complete  remission  rates 
and  to  determine  toxicities  of  each  treatment  Arm.  The  trial  will  also  investigate  the  prognostic 
significance  of  CD33  expression,  FLT-3  mutations,  and  the  flow  cytometric  detection  of  minimal 
residual  disease.  The  goal  accrual  of  this  trial  is  684  patients  over  5  years  with  an  expected 
enrollment  of  2  patients  per  year  at  MAMC. 

Progress:  This  protocol  remains  open  to  enrollment  with  no  patients  enrolled  during  FY06. 


153 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204034  Status:  Ongoing 

Title:  SWOG  S0221,  Phase  III  Trial  of  Continuous  Schedule  AC  +  G  Vs.  Q  2  Week  Schedule  AC, 
Followed  by  Paclitaxel  Given  Either  Every  2  Weeks  or  Weekly  for  12  Weeks  as  Post-Operative 
Adjuvant  Therapy  in  Node-Positive  or  High-Risk  Node-Negative  Breast  Cancer 


Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

2/26/2004  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  (1)  To  compare  the  disease-free  survival  of  patients  with  node-positive  or  high- 
risk  node-negative  breast  cancer  treated  with  the  combination  of  doxorubicin  and 
cyclophosphamide  given  every  2  weeks  with  Pegfilgrastim  support  with  that  of  patients  treated 
with  weekly  doxorubicin  and  daily  oral  cyclophosphamide  with  filgrastim  support,  with  both 
treatments  to  be  followed  by  paclitaxel  given  according  to  one  of  two  schedules.  (2)  To  compare  the 
disease-free  survival  of  patients  with  node-positive  or  high-risk  node-negative  breast  cancer 
treated  with  either  12  weeks  of  weekly  paclitaxel  or  paclitaxel  given  every  2  weeks  with 
Pegfilgrastim  support  for  6  cycles  following  treatment  with  one  of  the  two 
doxorubicin/cyclophosphamide  regimens  discussed  above.  (3)  To  compare  the  overall  survival 
produced  by  the  four  treatment  arms.  (4)  To  compare  the  toxicity  of  the  four  treatment  arms.  (5) 

To  examine  the  association  of  putative  prognostic  markers  with  outcome  and  the  interaction  of 
these  markers  with  treatment. 

Technical  Approach:  This  is  a  4-arm  phase  III  randomized  trial  of  two  different  dose- dense 
doxorubicin  plus  cyclophosphamide  chemotherapy  regimens  followed  by  two  different  schedules  of 
taxol  administration  used  for  the  treatment  of  node  positive  and  high  risk  node  negative  breast 
cancer.  Major  endpoints  of  the  trial  are  disease  free  survival  and  overall  survival  with  an 
anticipated  accrual  of  2000  patients  per  year  for  a  goal  of  4500  patients  accrued  over  2.2  years. 

The  study  DSMC  will  perform  an  interim  analysis  at  years  2.5,  4  and  6. 

Progress:  This  protocol  is  open  to  enrollment  with  16  patients  enrolled.  One  patient  is  deceased 
and  the  others  remain  on  treatment. 


154 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204094 

Status:  Ongoing 

Title:  SWOG  S0226,  Phase  III  Randomized  Trial  of  Anastrozole  Versus  Anastrozole  and 
Fulvestrant  as  First  Line  Therapy  for  Post  Menopausal  Women  With  Metastatic  Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

9/29/2004  -  Jun  2010  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

6/6/2006 

Study  Objective:  (1)  To  compare  time  to  tumor  progression  in  post-menopausal  women  with 
metastatic  breast  cancer  treated  with  Anastrozole  versus  Anastrozole  and  Fulvestrant.  (2)  To 
compare  clinical  benefit  (CR,  PR,  confirmed  or  unconfirmed,  or  stable  disease  >24  weeks)  and 
overall  survival  for  this  cohort  of  patients.  (3)  To  assess  the  adverse  events  of  Anastrozole  as 
compared  to  Anastrozole  and  Fulvestrant  in  this  cohort  of  patients.  (4)  To  assess  the  prognostic 
significance  of  subtypes  of  ER  positive  and  HER-2  status.  (5)  To  assess  parameters  of  estrogen  and 
clinical  pharmacology  and  estrogen  levels  as  outlined  in  Sec.  15.4.  (6)  To  compare  the  Anastrozole 
plasma  levels  on  each  treatment  arm  at  8  weeks,  16  weeks  and  24  weeks  after  randomization. 

Technical  Approach:  S0226  is  a  randomized  Phase  III  trial  of  Anastrozole  versus  Anastrozole 
plus  Fulvestrant  as  first  line  endocrine  therapy  for  metastatic  breast  cancer.  The  end-points  of  the 
trial  are  to  assess  the  time  to  tumor  progression  of  each  of  these  treatments,  to  assess  response 
rates  and  to  assess  overall  survival  of  patients.  The  trial  will  also  assess  the  adverse  effects  of  each 
treatment  arm  and  the  prognostic  significance  of  tumor  ER  status  and  HER2  status. 
Pharmacokinetic  data  on  Anastrozole  plasma  levels  and  serum  estradiol  levels  will  be  measured  in 
both  treatment  groups.  The  trial  has  a  national  goal  accrual  of  230  patients  per  year  for  3  years, 
with  a  goal  accrual  of  5  patients  per  year  here  at  Madigan.  All  data  evaluation  will  be  done 
through  the  SWOG.  There  will  be  a  planned  interim  analysis  of  progression  free  survival  after  50% 
and  75%  of  national  goal  accrual. 

Patients  will  be  randomized  to  receive  either  1  mg  Anastrozole  by  mouth  every  day  or  1  mg 
Anastrozole  orally  every  day  and  250  mg  of  Fulvestrant  intramuscular  injection  once  every  28 
days.  This  schedule  will  continue  until  disease  worsens  or  side  effects  are  unacceptable. 
Fulvestrant  may  be  given  if  disease  worsens  and  if  other  treatment  is  not  required  right  away.  The 
first  fifty  patients  in  each  group  will  have  blood  drawn  to  measure  drug  levels. 

Progress:  This  protocol  remains  open  to  enrollment,  with  no  patients  enrolled. 


155 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204064  Status:  Ongoing 

Title:  SWOG  S0230,  Phase  III  Trial  of  LHRH  Analog  Administration  During  Chemotherapy  to 
Reduce  Ovarian  Failure  Following  Chemotherapy  in  Early  Stage,  Hormone-  Receptor  Negative 
Breast  Cancer 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
John  B.  Halligan,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/27/2004  -  Apr  2009  SWOG  via  Henry  M.  Jackson  Foundation  4/20/2006 

Study  Objective:  (1)  To  compare  the  rate  of  premature  ovarian  failure  at  two  years  following 
standard  adjuvant  chemotherapy  with  or  without  the  addition  of  ovarian  suppression  with  a 
LHRH  analog  during  chemotherapy  in  premenopausal  women  with  early  stage,  hormone-receptor 
negative  breast  cancer.  (2)  To  compare  rates  of  ovarian  dysfunction  at  one  year  and  two  years 
following  standard  adjuvant  chemotherapy  with  or  without  ovarian  suppression  and  to  evaluate 
ovarian  reserve  in  the  two  groups  at  one  and  two  years.  In  addition,  this  study  will  describe 
pregnancy  and  other  fertility  information  in  the  two  groups  after  treatment  and  during  the  five 
year  follow-up  period. 

Technical  Approach:  This  is  a  randomized  national  phase  III  trial  comparing  standard  adjuvant 
chemotherapy  with  chemotherapy  plus  Goserelin  in  pre-menopausal  women  with  Stage  I,  II  or 
IIIA  Estrogen  receptor  negative  and  progesterone  receptor  negative  breast  cancer.  Suppression  of 
ovarian  function  during  chemotherapy  with  a  LHRH  analog  has  demonstrated  high  rates  of 
ovarian  preservation  in  small  studies.  Outcome  variables  include  the  rate  of  amenorrhea  at  the 
completion  of  chemotherapy,  at  one  year  and  at  two  years  following  treatment.  Serum  levels  of 
FSH,  estradiol  and  inhibin  B  will  also  be  obtained  at  these  same  time  points.  Fertility  information 
to  include  the  number  of  successful  pregnancies  and  the  number  of  miscarriages  will  be  compared 
at  one,  two  and  five  years  after  treatment.  National  accrual  is  416  patients  over  three  years  of 
which  an  estimated  3  per  year  will  be  enrolled  at  MAMC. 

Progress:  This  study  remains  open  to  enrollment,  with  no  patients  enrolled. 


156 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206068 

Status:  Ongoing 

Title:  SWOG  S0520:  Phase  II  Study  of  PXD101  (NSC-726630)  in  Relapsed  and  Refractory 
Aggressive  B-Cell  Lymphomas 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

7/24/2006  -  May  2011  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Primary  objectives:  (1)  To  evaluate  response  rate  and  toxicity  in  patients  with 
relapsed  and  refractory  aggressive  B-cell  lymphoma  treated  with  this  regimen.  (2)  To  estimate  the 
6-month  progression-free  survival  rate  in  patients  with  relapsed  and  refractory  aggressive  B-cell 
lymphoma  with  single  agent  PXD101  therapy.  Correlative  study  objectives:  (1)  to  assay  the  MHC 
Class  II  proteins  (HLA-DR,  DP,  DQ),  TUNEL  and  CD8  infiltration  status  by 
immunohistochemistry  on  paired  pre-  and  post-treatment  tumor  samples  for  20  patients  on  the 
enrolled,  (2)  to  measure  CIITA  and  HLA-DR  mRNA  expression  using  quantitative  RT-PCR,  and  to 
explore  in  a  preliminary  manner  the  associations  of  these  markers  and  progression-free  survival 
and  (3)  to  evaluate  paired  pre-  and  post-treatment  peripheral  blood  mononuclear  cells  (PBMCs) 
from  patient  for  histone  acetylation  conducted  on  pre-  and  post-needle  core  biopsies. 

Technical  Approach:  This  is  a  Phase  II,  open  label,  multi-site  study  of  PXD101  in  relapsed  and 
refractory  aggressive  B-cell  lymphoma.  This  study  will  enroll  a  total  of  60  subjects  (up  to  3  at 
MAMC)  with  diffuse  large,  Burkitt's,  Burkitt-like,  primary  mediastinal  lymphoma.  Patients  will 
receive  PXD101  at  a  dose  of  1,000  mg/m2,  as  a  30  minute  IV  infusion,  on  Days  1-5  of  a  21  day 
cycle.  Nausea,  vomiting,  anemia,  neutropenia  and  dehydration  will  be  treated  according  to 
institutional  standards.  Diarrhea  will  be  treated  with  loperamide.  Treatment  will  be  given  on 
Days  1-5  of  a  21  Day  cycle.  Physicals,  laboratory  tests  and  adverse  event  evaluation  will  be  done 
prior  to  each  subsequent  cycle.  Disease  assessment  will  be  done  after  Cycle  3,  and  then  every  4 
cycles  until  progression  is  documented.  Patients  will  be  removed  from  treatment  after  disease 
progression,  symptomatic  deterioration,  unacceptable  toxicity  or  completion  of  2  years  of 
treatment.  Off-treatment  evaluation  will  include  monitoring  for  disease  progression  and  survival 
for  up  to  a  total  of  3  years.  The  primary  goal  of  this  study  is  to  assess  the  response  probability  in 
patients  with  relapsed  or  refractory  aggressive  B-cell  lymphoma  treated  with  PXD101.  Secondary 
endpoints  will  include  toxicity,  overall  survival,  time  to  treatment  failure  and  time  to  progression. 
It  is  assumed  that  this  therapy  will  be  of  no  further  interested  if  the  true  response  probability  is 
5%  or  less,  and  of  interest  if  the  true  response  probability  is  20%  or  more.  The  study  has  a  two- 
stage  design.  If  at  least  one  of  the  first  20  patients  responds,  an  additional  20  patients  will  be 
enrolled. 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled  during  FY06. 


157 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  91094  Status:  Ongoing 

Title:  SWOG  S9007  (ECOG  S9007),  Cytogenetic  Studies  in  Leukemia  Patients 
Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/7/1992  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation  1/12/2006 

Study  Objective:  (1)  To  estimate  the  frequencies  and  prognostic  significance  of  cytogenetic 
abnormalities  in  marrow  or  blood  cells  of  leukemia  patients  prior  to  treatment  on  Southwest 
Oncology  Group  protocols  and  at  various  times  in  the  course  of  their  treatment,  (2)  To  estimate 
correlations  between  the  presence  of  cytogenetic  features  and  of  clinical,  pathophsiological, 
cellular,  or  molecular  characteristics  in  these  patients  and  (3)  To  provide  quality  control  for  all 
Southwest  Oncology  Group  cytogenetic  data. 

Technical  Approach:  This  is  a  companion  protocol  for  all  Southwest  Oncology  Group  leukemia 
protocols.  Bone  marrow  or  peripheral  blood  specimens  will  be  forwarded  to  a  SWOG  referral 
cytogenetics  laboratory  (Oregon  Health  Sciences  University,  Portland,  Oregon  is  the  nearest  to 
Madigan  Army  Medical  Center).  The  referral  lab  will  return  a  cytogenetics  report  to  MAMC. 
Specimens  will  be  collected  as  outlined  in  each  individual  leukemia  protocol. 

Progress:  This  protocol  is  the  cytogenetic  companion  study  to  SWOG  leukemia  treatment  protocol 
SO  106.  It  remains  open  to  enrollment  with  no  subjects  enrolled. 


158 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  99019 

Status:  Ongoing 

Title:  SWOG  S9808:  Long-Term  Follow-Up  Protocol:  An  Administrative  Tool 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding: 

10/20/1998  -  Indef  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

10/10/2006 

Study  Objective:  To  relieve  the  burden  on  Institutional  Review  Boards  at  Southwest  Oncology 
Group  Institutions  for  continuing  review  of  protocols  that  are  closed  to  patient  registration,  and  on 
which  no  patients  are  currently  receiving  protocol  treatment. 


Technical  Approach:  When  a  study  has  been  closed  to  patient  accrual  and  patients  have 
finished  treatment,  it  still  requires  submission  of  data  to  the  Southwest  Oncology  Group  to  report 
survival  and  remission  status  and  occurrence  of  adverse  events.  On  an  annual  basis,  the 
Southwest  Oncology  Group  Operations  Office  will  notify  the  institutions  as  to  which  protocols  are 
eligible  for  transfer  to  the  Long  Term  Follow-Up  protocol  by  periodically  revising  the  list  of 
applicable  protocols.  The  institutional  Principal  Investigator  or  IRB  will  ultimately  decide  for  the 
local  institution  whether  the  protocol  should  be  included  in  this  protocol  or  continue  to  be  reviewed 
on  its  own.  A  report  will  be  prepared  and  submitted  for  annual  IRB  review  at  individual 
institutions.  This  report  will  include  title  and  date  closed  to  patient  entry. 

Progress:  During  FY06,  the  following  protocols  continued  to  have  patients  followed  under  this 
long-term  follow-up  tool:  8516,  1  patient;  8794,  1  patient;  8809,  2  patients;  9008,  1  patient;  9035,  1 
patient;  9133,  2  patients;  9304,  1  patient;  and  9349,  2  patients. 

Protocols  terminated  during  FY06  and  patients  added  to  this  administrative  tool  are:  8814,  3 
patients;  8897,  6  patients;  and  9313  1  patient. 

Protocols  that  no  longer  required  follow-up  data  during  FY06:  8294,  5  patients;  9003,  1  patient; 
and  9415,  1  patient. 


159 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205035 

Status:  Ongoing 

Title:  SWOG  S9910  Leukemia  Centralized  Reference  Laboratories  and  Tissue  Repositories, 
Ancillary 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding: 

3/18/2005  -  Feb  2010  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

1/4/2006 

Study  Objective:  (1)  To  develop  and  apply  laboratory  assays  for  the  rapid  and  precise  diagnosis 
of  leukemia  patients  and  identify  biologic,  genetic,  and  molecular  parameters  that  distinguishes 
different  subtypes  of  human  leukemia  with  differing  responses  to  therapy.  (2)  To  develop  risk- 
adapted'  therapeutic  approaches  in  which  biologic,  genetic,  and  molecular  parameters  are  sued  to 
target  individual  patients  to  tailored  therapeutic  regimens,  or,  to  randomize  and  stratify  patients 
to  different  treatment  arms  of  a  therapeutic  trial.  (3)  To  develop  new  automated  and  standardized 
laboratory  methods  for  the  detection  and  monitoring  of  therapeutic  responsiveness  and  minimal 
residual  disease  in  leukemia  patients  and  develop  new  clinical  approaches  to  employ  such  data  in 
therapeutic  decision  making  and  clinical  trial  design.  (4)  To  maintain  and  expand  tissue 
repositories  of  highly  characterized  leukemia  samples  from  uniformly  treated  Southwest  oncology 
Group  patients  to  promote  Intergroup  and  external  fundamental  scientific  collaborations  and  to 
perform  continued  critical  prospective  and  retrospective  correlative  biologic  studies.  (5)  To  utilize 
scientific  information  generated  from  Intergroup  and  collaborative  studies  to  assist  the  leukemia 
committee  in  the  development  of  new  and  more  effective  treatment  regimens. 

Technical  Approach:  The  Southwest  Oncology  Group  repositories  are  banks  of  extremely 
valuable  leukemia  samples  which  are  made  available  to  researchers  who  are  studying  various 
biological  parameters  and  therapeutic  diseases. 

Progress:  This  protocol  remains  open  to  enrollment,  with  no  patients  enrolled. 


160 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200084  Status:  Ongoing 

Title:  SWOG  S9921:  Adjuvant  Androgen  Deprivation  versus  Mitoxantrone  plus  Prednisone  plus 
Androgen  Deprivation  in  Selected  High  Risk  Prostate  Cancer  Patients  Following  Radical 
Prostatectomy,  Phase  III 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/26/2000  -  Jan  2002  SWOG  via  Henry  M.  Jackson  Foundation  5/23/2006 

Study  Objective:  This  study  will  evaluate  overall  survival  using  adjuvant  systemic  therapy  in 
high  risk  localized  prostate  cancer  patients  following  radical  prostatectomy.  Disease-free  survival 
will  also  be  evaluated.  Patients  will  be  randomized  to  one  of  the  following  two  treatment  arms:  (A) 
Casodex,  +  Zoladex,  (B)  Novantrone/Prednisone  followed  by  Casodex,  +  Zoladex.  This  study  will 
also  compare  qualitative  and  quantitative  toxicity  between  the  two  study  arms. 

Technical  Approach:  This  study  compares  standard  hormonal  therapy  after  prostate  cancer 
surgery  to  standard  therapy  plus  chemotherapy  to  determine  the  best  way  to  prevent  relapse. 
Subjects  will  be  randomized  to  receive  either  Treatment  1,  Hormonal  Therapy  which  consists  of 
Zoladex,  subcutaneous  injection  once  every  12  weeks  for  two  years  or  Treatment  2,  Hormonal 
Therapy  plus  Mitoxantrone  plus  Prednisone  which  consists  of  Zoladex  subcutaneous  injection  once 
every  12  weeks  for  two  years,  Casodex  taken  orally  once  a  day  for  two  years,  Mitoxantrone,  IV 
once  every  21  days  for  126  days  (6  cycles)  and  Prednisone,  taken  orally  twice  a  day  for  126  days. 
Following  study  completion,  subjects  will  be  followed  every  6  months  for  two  years  to  assess 
response. 

Progress:  This  protocol  is  open  to  patient  entry,  with  thirteen  patients  enrolled  to  date.  Five 
patients  continue  to  receive  study  treatment;  the  remaining  eight  patients  continued  to  be  followed 
at  MAMC  during  FY06. 


161 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  202074 

Status:  Ongoing 

Title:  SWOG  S9925  Lung  Cancer  Specimen  Repository  Protocol,  Ancillary 

Principal  Investigator:  MAJ  Jasmine  T.  Daniels,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding: 

Periodic  Review: 

9/24/2002  -  Nov  2005  SWOG  via  Henry  M.  Jackson  Foundation 

5/22/2006 

Study  Objective:  (1)  To  establish  a  central  lung  cancer  specimen  repository  to  serve  as  a  resource 
for  current  and  future  scientific  studies.  (2)  To  utilize  Southwest  Oncology  Group  clinical  database 
to  perform  clinic  pathologic  correlation  with  the  results  of  those  studies.  (3)  To  test  new  hypotheses 
as  they  emerge. 

Technical  Approach:  Patients  enrolled  into  select  other  SWOG  lung  cancer  studies  will  be  asked 
to  consent  to  this  study  as  well.  Tissue  samples  will  be  obtained  and  stored. 

Progress:  This  protocol  is  a  companion  study  to  other  SWOG  lung  cancer  treatment  trials  and 
remains  open  to  patient  entry,  with  three  patients  enrolled  at  MAMC;  all  now  deceased. 


162 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204073  Status:  Ongoing 

Title:  A  Multicenter,  Randomized,  Phase  III  Study  of  Rituximab  versus  Iodine  I  131 

Tositumomab  Therapeutic  Regimen  for  Patients  with  Relapsed  Follicular  Non-Hodgkin's 

Lymphoma,  Protocol  CCBX001-049 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 

Maricela  Contreras,  MC;  COL  Marc  G.  Cote,  MC;  LTC  Antonio  G.  Balingit,  MC;  Jane  E.  Besich- 

Carter,  BS,  BCNP 

Start  -  Completion:  Funding:  Periodic  Review: 

7/26/2004  -  Jun  2016  Corixa  Corporation  via  Henry  M.  Jackson  4/20/2006 

Foundation 

Study  Objective:  (1)  To  compare  the  event-free  survival,  as  assessed  by  a  Masked  Independent 
Randomized  Radiographic  and  Oncologic  Review  (MIRROR)  Panel,  of  patients  treated  with 
rituximab  to  that  of  patients  treated  with  the  Iodine  1-131  Tositumomab  therapeutic  regimen  in 
patients  who  have  had  at  least  one,  but  no  more  than  two,  prior  therapies  for  follicular  non- 
Hodgkin's  lymphoma  (NHL).  (2)  To  compare  confirmed  response  rates,  durations  of  response,  time 
to  next  treatment,  and  progression-free  survival  of  patients  treated  with  rituximab  to  that  of 
patients  treated  with  the  Iodine  1-131  Tositumomab  therapeutic  regimen  in  patients  who  have  had 
at  least  one,  but  no  more  than  two,  prior  therapies  for  follicular  NHL,  as  assessed  by  a  MIRROR 
panel,  to  compare  overall  survival  in  these  two  treatment  groups,  and  to  assess  and  compare  the 
safety  of  rituximab  and  Iodine  1-131  Tositumomab  when  administered  to  this  patient  population. 
(3)  To  summarize  safety  and  efficacy  outcomes  during  follow-up  after  subsequent  therapy  for  NHL 
for  patients  in  both  arms  who  receive  additional  therapy. 

Technical  Approach:  This  is  a  multicenter,  randomized,  Phase  3  trial  to  compare  rituximab  and 
the  Iodine  I  131  Tositumomab  therapeutic  regimen  in  the  treatment  of  subjects  with  follicular  non- 
Hodgkin's  B-cell  lymphoma.  Randomization  will  be  stratified  by  prior  rituximab  treatment,  first 
versus  second  relapse,  and  region,  (US  or  outside  the  US).  In  Arm  A,  subjects  will  receive  375 
mg/m2  of  rituximab  as  an  IV  infusion  once  weekly  for  4  weeks.  In  Arm  B,  subjects  will  undergo  a 
two  phase  treatment.  In  the  dosimetric  phase,  subjects  will  receive  an  infusion  of  unlabeled 
Tositumomab  (450mg)  immediately  followed  by  an  infusion  of  5  mCi  (0.18  GBq)  of  Iodine  I  131 
Tositumomab  (35  mg.)  Whole  body  gamma  camera  scans  will  be  obtained  3  times  after  the 
dosimetric  dose.  A  patient-specific  administered  activity  of  Iodine  I  131  Tositumomab  will  be 
calculated  to  deliver  the  desired  total  body  dose  of  radiation  (65  or  75  cGy). 

In  the  second  phase  (therapeutic  dose),  subjects  in  Arm  B  will  receive  an  infusion  of  unlabeled 
Tositumomab  (450mg)  immediately  followed  by  infusion  of  the  patient-specific  activity  of  Iodine  I 
131-conjugated  Tositumomab  (35  mg.)  Thyroid  blockade  will  be  implemented  24  hours  prior  to  the 
dosimetric  dose  and  continued  for  14  days  following.  Hematology  and  serum  chemistry  will  be 
measured  for  safety  assessments  weekly  (hematology)  and  approximately  monthly  (chemistry) 
through  Week  13,  then  at  scheduled  study  follow  up  visits.  Approximately  506  subjects  will  be 
randomized  in  the  trial,  and  about  6  will  participate  at  MAMC.  The  study  will  be  conducted  in  the 
Hematology  and  Oncology  Clinic  in  collaboration  with  the  Nuclear  Medicine  Service.  Subject 
accrual  will  continue  for  about  2  years.  Subjects  will  be  followed  for  response  and  safety 
measurements  at  weeks  7  and  13  and  every  3  months  for  the  first  and  second  year,  every  6  months 
for  the  third  year,  annually  for  the  fourth  and  fifth  years,  then  for  long  term  follow  up  for  survival, 
safety,  and  additional  therapy  data  through  year  ten.  After  subsequent  NHL  therapy,  follow  up 
will  assess  tolerance  of  next  anti-lymphoma  therapy,  development  of  NDS/AML,  HAMA,  or 


163 


hypothyroidism,  unexpected  safety  issues,  and  death. 

The  primary  analysis  is  the  intent  to  treat  comparison  of  event-free  survival  between  treatment 
arms,  which  will  be  based  on  the  MIRROR  panel  assessment  of  event-free  survival.  Secondary 
analyses  will  include  the  comparison  of  response  rates  and  complete  response  rates  (confirmed) 
and  separate  analyses  will  evaluate  other  responses,  duration,  time  to  next  treatment,  and  overall 
survival.  Secondary  and  exploratory  analyses  will  include  a  stratified  log  rank  test  adjusting  for 
stratification.  Kaplan-Meier  formula  will  be  used  to  estimate  duration  curves  and  percentiles. 
Estimates  and  confidence  limits  will  be  calculated  by  the  product  limit  method  and  Greenwood's 
formula  for  variance.  Safety  will  be  summarized  within  treatment  arms  and  compared  across 
treatment  arms. 

Progress:  This  protocol  remains  open  to  enrollment  with  no  patients  screened  or  enrolled  during 
FY06. 


164 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205093  Status:  Ongoing 

Title:  A  Phase  3,  Double-Blind,  Placebo- Controlled  Study  of  Maintenance  Premetrexed  plus  Best 
Supportive  Care  versus  Best  Supportive  Care  Immediately  Following  Induction  Treatment  for 
Advanced  Non-Small  Cell  Lung  Cancer  AND  COMPANION  STUDY  Companion  Translational 
Research  Protocol 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

10/27/2005  -  Aug  2010  Eli  Lilly  and  Company  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

7/20/2006 

Study  Objective:  (1)  To  compare  maintenance  therapy  with  Premetrexed  plus  best  supportive 
care  (BSC)  versus  placebo  plus  BSC,  in  terms  of  the  overall  survival  time  (OS)  in  patients  with 
Stage  IIIB  (with  pleural  effusion  and/or  positive  supraclavicular  lymph  nodes)  or  IV  NSCLC  who 
have  not  progressed  during  four  cycles  of  platinum-based  induction  chemotherapy.  (2)  To  compare 
the  following  between  the  randomized  treatment  arms:  Time  to  event  efficacy  endpoints: 
Progression-free  survival  time  (PFS),  Time  to  objective  progressive  disease  (TPD),  Time  to 
worsening  of  symptoms  (TWS),  Objective  tumor  response  rate,  Adverse  events,  and  Changes  in 
individual  symptom  scores  and  quality  of  life  using  the  Lung  Cancer  Symptom  Scale  (LCSS). 

Technical  Approach:  This  is  a  phase  3,  global,  multicenter,  randomized,  double-blind,  placebo- 
controlled  study  to  compare  maintenance  therapy  with  Premetrexed  plus  BSC  versus  placebo  in 
terms  of  overall  survival  time  in  patients  with  stage  IIIB  (with  pleural  effusion  and/or  positive 
supraclavicular  lymph  nodes)  or  stage  IV  NSCLC  who  have  not  progressed  during  four  cycles  of 
platinum-based  induction  chemotherapy.  Eligible  patients  will  be  randomly  assigned  to  receive 
Premetrexed  plus  BSC  or  placebo  plus  BSC.  Patients  in  both  treatment  arms  will  receive  folic  acid, 
vitamin  B12  supplements  and  dexamethasone.  Each  patient  will  undergo  a  treatment  period  and  a 
follow-up  period.  The  treatment  period  consists  of  21  day  treatment  cycles.  Patients  will  receive 
treatment  (control  or  experimental)  until  objective  disease  progression.  The  follow-up  period 
begins  when  the  patient  discontinues  study  treatment.  Patients  are  to  be  followed  with  a  periodic 
tumor  response  evaluation  until  objective  disease  progression.  All  patients  will  be  followed  until 
death  or  study  closure. 

The  study  will  apply  technology  to  evaluate  intratumoral  gene  expression,  followed  by  protein 
expression  and  DNA  polymorphisms  of  key  genes  involved  in  the  cellular  transport,  activation  and 
cytotoxic  activity  of  Premetrexed.  All  subjects  entered  into  the  clinical  study  will  be  invited  to 
participate  in  the  companion  protocol.  Samples  will  be  shipped  to  the  sponsor  Eli  Lilly  and 
Company  and  will  be  stored  for  a  maximum  of  3  years  after  the  companion  study  is  completed  and 
then  the  tissue  samples  will  be  destroyed. 

Progress:  This  protocol  remains  open  to  enrollment  with  no  subjects  screened  or  consented  during 
FY06. 


165 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206014 

Status:  Ongoing 

Title:  A  Phase  I/II  Trial  of  Zometa  in  Patients  with  Monoclonal  Gammopathy  of  Undetermined 
Significance  (MGUS) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

6/6/2006  -  July  2010  Oncotherapeutics  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

10/16/2006 

Study  Objective:  To  determine  the  effect  of  zoledronic  acid  on  bone  mineral  density  (BMD)  of 
lumbar  spine,  utilizing  dual  energy  x-ray  absorptiometry  (DEXA)  scan,  among  patients  with 
MGUS  with  associated  osteopenia/osteoporosis.  The  secondary  objectives  of  this  study  are  to: 
determine  the  effect  of  zoledronic  acid  on  skeletal  fractures  in  MGUS  patients  with 
osteopenia/osteoporosis,  determine  the  effect  of  zoledronic  acid  on  BMD  of  total  hip,  determine  the 
effect  of  zoledronic  acid  on  serum  M-protein  levels,  determine  the  proportion  of  patients  treated 
with  zoledronic  acid  that  develop  multiple  myeloma  or  other  related  malignancies,  and  determine 
the  safety  of  the  use  of  zoledronic  acid  in  the  treatment  of  MGUS  patients  with 
osteopenia/osteoporosis. 

Technical  Approach:  This  is  an  open  label  study  designed  to  evaluate  the  efficacy  and  safety  of 
zoledronic  acid  in  MGUS  patients  with  osteopenia/osteoporosis.  A  screening  visit  will  be  conducted 
within  14  days  before  baseline  (baseline  being  prior  to  the  administration  of  the  first  dose  of  study 
drug).  At  this  visit,  a  medical  history  will  be  obtained  and  a  complete  physical  examination  will  be 
performed  including  vital  signs,  weight,  12-lead  electrocardiogram,  and  postero-anterior  and 
lateral  chest  x-rays.  Pre-study  disease  assessment  will  be  performed,  including  bone  mineral 
density  (BMD)  of  lumbar  spine,  Karnofsky  Performance  Status  (KPS),  skeletal  survey,  bone 
marrow  aspirate  and  biopsy  (patients  will  be  required  to  have  this  procedure  if  bone  marrow 
aspirate  and  biopsy  has  never  been  performed  to  rule  out  the  possibility  of  malignancy),  serum  and 
urine  protein  electrophoreses.  The  bone  marrow  aspirate  and  biopsy  will  be  evaluated  for  degree  of 
plasma  cell  involvement.  Clinical  laboratory  tests  including  hematology,  clinical  chemistry 
(including  electrolytes,  calcium,  magnesium  and  random  glucose),  liver  tests,  urinalysis,  and 
serum  pregnancy  tests  for  women  of  child-bearing  potential  will  also  be  performed  at  the 
Screening  visit.  Patients  who  meet  the  eligibility  requirements  as  assessed  at  the  Screening  visit 
will  be  enrolled  in  the  study.  Zoledronic  acid  at  4  mg  will  be  administered  intravenously  every  6 
months  over  a  period  of  12  months.  Patients  are  to  attend  a  Final  study  visit.  Procedures  to  be 
conducted  at  this  visit  include  a  complete  physical  examination,  adverse  event  assessment,  vital 
signs,  Karnofsky  performance  status  assessment  and  clinical  chemistry. 

Progress:  This  protocol  opened  to  patient  entry  in  June  2006;  no  subjects  have  been  screened  or 
enrolled. 


166 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205016  Status:  Terminated 

Title:  A  Phase  II  Multicenter,  Randomized,  Double-blind,  Placebo-controlled  Dose-Ranging, 
Parallel  Group  Study  of  the  Safety  and  Efficacy  of  the  Oral  Neurokinin- 1  Receptor  Antagonist, 
GW679769,  When  Administered  as  50mg,  lOOmg,  and  150mg  Oral  Tablets  in  Combination  with 
Ondansetron  Hydrochloride  and  Dexamethasone  for  the  Prevention  of  Chemotherapy- Induced 
Nausea  and  Vomiting  in  Cancer  Subjects  Receiving  Moderately  Emetogenic  Chemotherapy 


Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

2/28/2005  -  Jan  2007  GlaxoSmithKline  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

11/3/2006 

Study  Objective:  Primary  objectives:  (1)  To  determine  the  optimal  dose  of  oral  GW679769  when 
administered  in  combination  with  ondansetron  hydrochloride  and  dexamethasone  for  the 
prevention  of  vomiting  during  the  first  120  hours  in  subjects  receiving  their  first  cycle  of 
moderately  emetogenic  chemotherapy.  (2)  To  determine  the  optimal  dose  of  oral  GW679769  when 
administered  in  combination  with  ondansetron  hydrochloride  and  dexamethasone  for  the 
prevention  of  nausea  during  the  first  120  hours  in  subjects  receiving  their  first  cycle  of  moderately 
emetogenic  chemotherapy. 

Secondary  objectives:  (1)  To  determine  the  safety  of  oral  GW679769  at  various  dose  levels 
when  administered  in  combination  with  ondansetron  hydrochloride  and  dexamethasone  in  subjects 
receiving  their  first  cycle  of  moderately  emetogenic  chemotherapy.  (2)  To  quantify  the  impact  on 
daily  life  activities  of  oral  GW679769  when  administered  in  combination  with  ondansetron 
hydrochloride  and  dexamethasone  during  the  first  120  hours  in  subjects  receiving  their  first  dose 
of  moderately  emetogenic  chemotherapy.  (3)  To  evaluate  the  population  pharmacokinetics  and 
pharmaco-dynamics  (PK/PD)  of  oral  GW679769  and  its  active  metabolites  when  administered  in 
combination  with  ondansetron  hydrochloride  and  dexamethasone  in  subjects  receiving  their  first 
cycle  of  moderately  emetogenic  chemotherapy. 

Technical  Approach:  This  trial  is  a  double-blind,  randomized,  placebo-controlled,  dose-ranging, 
parallel  group  study  of  the  safety  and  efficacy  of  the  oral  neurokinin- 1  receptor  antagonist 
GW679769.  At  MAMC,  the  study  will  be  conducted  by  the  Hematology/  Oncology  service  with  up  to 
20  subjects  enrolled  out  of  a  total  of  708  subjects  in  the  study  overall.  Subjects  scheduled  to  begin 
chemotherapy  with  a  moderately  emetogenic  regimen  will  be  consented  and  screened  in  the 
oncology  service.  On  day  1  prior  to  the  first  chemotherapy  cycle,  subjects  will  be  administered 
ondansetron  hydrochloride  (8mg  or  16  mg),  intravenous  Dexamethasone  (8mg)  and  an  oral  dose  of 
GW679769  investigational  produce  (active  or  placebo).  Subjects  in  groups  1,  2,  3,  4,  or  5  will 
receive  a  second  dose  of  oral  ondansetron  hydrochloride  8  hours  following  the  initial  dose. 
Subsequent  dose  or  doses  of  ondansetron  hydrochloride  will  be  administered  bid  on  days  2  and  3. 
For  treatment  group  6,  the  initial  daily  dose  of  ondansetron  hydrochloride  for  days  1,  2  and  3  will 
be  16mg,  followed  by  a  second  daily  dose  of  ondansetron  hydrochloride  placebo.  For  study  groups  1, 
2,  3,  4  and  6,  GW679769  will  be  administered  once  daily  on  study  days  2  and  3  at  the  same  dose  as 
day  1.  Subjects  randomized  to  group  5  will  receive  a  single  active  dose  of  GW679769  on  day  1,  and 
receive  a  single  daily  dose  of  GW679769  placebo  on  days  2  and  3.  For  study  subjects  who  are 
receiving  a  taxane  based  therapy,  Dexamethasone  will  not  be  given  according  to  protocol,  but  will 
be  given  according  to  MAMC  standard  procedure  for  that  specific  chemotherapy  regimen. 

Progress:  This  protocol  closed  to  enrollment  with  no  subjects  enrolled  at  MAMC.  A  final  site  close 
out  visit  was  conducted  in  November  2006. 


167 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205087  Status:  Suspended 

Title:  A  Phase  II,  Open  Label,  Multi-center  Study  of  EP2101  Therapeutic  Vaccine  in  Patients 

with  Stage  Illb,  Stage  IV,  or  Recurrent  Non-Small  Cell  Lung  Cancer  (NSCLC) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC;  LTC 

Mark  L.  Nelson,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

9/21/2005  -  Jul  2010  Epimmune  via  Henry  M.  Jackson  Foundation  6/27/2006 

Study  Objective:  (1)  To  compare  the  overall  survival  of  patients  with  stage  Illb,  IV,  or  recurrent 
non-small  cell  lung  cancer  treated  with  EP2101  therapeutic  vaccine  to  a  concurrent  non-HLA-A2 
observation  group  and  historical  controls.  (2)  To  evaluate  the  safety  of  EP2101  therapeutic  vaccine. 
Secondary:  (1)  To  determine  progression-free  survival  time  in  patients  treated  with  EP2101 
therapeutic  vaccine.  (2)  To  determine  the  frequency,  magnitude,  and  breadth  of  cytotoxic  and 
helper  T-Cell  responses  to  EP2101  vaccine  epitopes. 

Technical  Approach:  At  MAMC,  the  study  will  be  conducted  by  the  Hematology/Oncology 
Service  with  up  to  12  MAMC  subjects  expected  to  enroll,  about  6  in  the  vaccine  group  and  6  in  the 
observational  group.  A  total  of  168  subjects  may  be  enrolled  in  the  study  overall.  Patients  who 
qualify  will  be  consented  to  have  their  HLA  type  tested.  Patients  who  do  not  qualify  for  the  vaccine 
portion  of  the  trial  will  be  consented  for  the  observational  arm  if  they  are  interested.  They  will 
have  a  baseline  medical  history  and  physical,  QOL,  laboratory  testing  including  CBC,  chemistry, 
urinalysis  and  pregnancy  test  if  applicable.  Observational  patients  will  be  seen  at  Wk9,  Wkl8, 
Wk22,  Mo6,  Mo7,  Mo9,  Mol2,  then  every  three  months  for  years  2  and  3,  and  annually  for  years  4 
and  5.  Visits  will  include  QOL,  con  meds,  disease  progression  and  survival  status. 

Patients  who  qualify  for  the  vaccine  arm  of  the  trial  (HLA  type  A2)  will  be  consented  and  have  the 
following  pre-study  assessment:  complete  medical  history  and  physical  exam,  ECOG  status 
performance,  concomitant  medications,  laboratory  testing  including  CBC,  chemistry,  ANA 
(autoimmunity),  urinalysis  and  pregnancy  testing  if  applicable,  ophthalmic  exam,  disease 
assessment  by  CT  or  MRI  scan,  and  Quality  of  Life  (QOL)  questionnaire.  These  patients  will  also 
be  referred  out  to  another  facility  to  have  leukapheresis  performed,  or  have  a  215  ml  blood  sample 
collected  using  a  pediatric  blood  unit  collection  bag,  to  submit  for  immunogenicity  and  helper  T-cell 
assays.  Patients  will  receive  the  study  vaccine  once  every  three  weeks  for  6  cycles,  for  a  total  of  18 
weeks  of  treatment.  Patients  will  be  monitored  by  the  research  nurse  in  the  clinic  for  observation 
for  60  minutes  after  each  vaccine,  to  assess  for  adverse  events.  At  Wk  9  and  18,  patients  will  have 
disease  assessments  done  by  CT  or  MRI,  QOL,  and  laboratory  tests  including  urinalysis,  ANA,  and 
blood  collected  for  immunogenicity  and  helper  T-cell  assays.  After  treatment,  patients  will  be 
followed  at  WK  22  and  Mo7  for  physical  exam  and  ECOG  score,  laboratory  tests  including  CBC 
and  chemistry,  adverse  event  and  con  med  assessment  and  survival  status.  In  addition,  at  Mo6, 

Mo  9  and  Mol2,  assessments  will  include  disease  progression  monitored  with  CT  or  MRI,  QOL, 
and  laboratory  tests  including  urinalysis,  ANA,  and  blood  collected  for  immunogenicity  and  helper 
T-cell  assays.  Long  term  follow  up  assessment  of  survival  status  will  be  scheduled  every  three 
months  for  years  2  and  3,  then  annually  for  years  4  and  5. 

Toxicities  will  be  graded  at  each  study  visit  according  to  the  National  Cancer  Institute  (NCI) 
Common  Toxicity  Criteria  (CTC)  Version  3.0.  Patients  will  be  withdrawn  from  treatment  for  > 
Grade  2  toxicity  of  allergic  reaction,  hypersensitivity,  autoimmune  reaction  or  vasculitis,  or  for  > 


168 


Grade  3  cytokine-like  release  reaction  or  local  skin  reaction.  The  study  will  be  placed  on  hold  for 
safety  review  if  toxicities  exceed  the  safety  criteria  outlined  on  Pg  37  of  the  protocol. 

Progress:  This  protocol  closed  to  enrollment  with  three  subjects  consented  and  enrolled.  One 
subject  had  disease  progression  and  is  no  longer  on  the  treatment  arm;  two  subjects  remain  on 
treatment. 


169 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205070 

Status:  Ongoing 

Title:  A  Phase  II  Study  Using  Alemtuzumab  Combined  with  Fludarabine  for  the  Treatment  of 
Relapsed/Refractory  B-cell  Chronic  Lymphocytic  Leukemia  (B-CLL) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

7/13/2005  -  Jun  2010  Berlex  Laboratories  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

4/20/2006 

Study  Objective:  The  primary  objective  is  to  evaluate  complete  response  rate  in  patients 
receiving  combination  treatment  with  Alemtuzumab  and  fludarabine.  The  secondary  objectives  are 
to  evaluate  over  all  response  rate,  survival  at  1  year,  time  to  progression,  duration  of  response, 
adverse  event  profile,  minimal  residual  disease  and  lymphocyte  and  lymphocyte  subset  recovery. 

Technical  Approach:  This  is  a  Phase  II,  open  label  trial  of  the  combination  of  alemtuzumab  and 
fludarabine  for  the  treatment  of  relapsed/refractory  B-cell  chronic  lymphocytic  leukemia.  This 
study  will  evaluate  the  response  rate,  survival,  time  to  progression,  duration  of  response 
lymphocyte  subset  recovery  and  safety  profile  of  the  combination  of  subcutaneous  alemtuzumab 
and  fludarabine.  Patients  will  receive  four  28-day  cycles  of  treatment  with  alemtuzumab  30  mg 
subcutaneously  followed  by  25mg/m2  IV  of  fludarabine,  daily  on  days  1  through  5.  At  the  end  of  4 
cycles,  patients  will  have  an  interim  assessment  to  determine  response  to  treatment.  This  will 
include  radiographs  as  needed  and  a  bone  marrow  biopsy.  Minimal  residual  disease  assessment 
will  be  performed  on  the  marrow  samples.  Patients  who  have  respond  or  have  stable  disease  will 
receive  two  additional  cycles  of  chemo  as  in  Cycles  1-4.  After  treatment  is  completed,  subjects  will 
be  followed  up  every  6  months  for  disease  assessment,  CMV,  and  flow  cytometry  for  lymphocyte 
subset  analysis  to  be  done  monthly  until  CD4  and  CD8  T  cell  counts  recover  to  >200  cells/uL. 

All  patients  will  be  prescribed  Bactrim  for  PCP  prophylaxis  and  famcyclovir  for  HSV  prophylaxis 
starting  with  Day  1,  and  continuing  for  at  least  2  months  after  treatment,  or  until  CD  4  counts  are 
>200  cells/  uL.  Patients  will  be  monitored  for  CMV  status  throughout  the  study  and  for  6  months 
after  treatment.  If  patients  become  CMV  positive  they  will  receive  appropriate  anti- CMV  therapy 
and  may  have  study  drug  delayed  until  CMV  treatment  is  complete.  Growth  factors  may  be  used 
at  the  discretion  of  the  investigator  for  Grade  3  or  4  neutropenia,  however  TPO  and  pegfilgrastim 
will  not  be  allowed.  Toxicities  will  be  graded  at  each  study  visit  according  to  the  National  Cancer 
Institute  (NCI)  Common  Toxicity  Criteria  (CTC)  Version  3.0  Safety  will  be  assesses  through 
physical  examinations  and  laboratory  assessments  at  each  study  visit. 

Progress:  This  protocol  was  closed  to  enrollment  at  MAMC  due  to  a  lack  in  screening  and 
enrollment  activity. 


170 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206126  Status:  Ongoing 

Title:  A  Phase  II  Trial  of  Imatinib  (Gleevec)  Plus  Gemcitabine  In  Patients  With  Ovarian 

Carcinoma  Who  Have  Failed  At  Least  One  Prior  Chemotherapy 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  MAJ 

Richard  D.  Reed,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/20/2006  -  Oct  2011  ACOSOG  via  Henry  M.  Jackson  Foundation  N/A 

Study  Objective:  (1)  To  evaluate  the  cytostatic,  anti-tumor  activity  of  the  combination  of 
Gleevec™  (Imatinib  Mesylate)  and  gemcitabine  via  progression-free  survival  for  at  least  six 
months  in  subjects  with  recurrent  or  persistent  epithelial  ovarian  or  primary  peritoneal 
carcinoma.  (2)  To  assess  the  tumor  response  rates  using  modified  SWOG  criteria  to  the 
combination  of  Gleevec™  (Imatinib  Mesylate)  and  gemcitabine  in  subjects  with  relapsed  ovarian 
cancer  who  have  failed  at  least  one  prior  chemotherapy  treatment.  (3)  To  determine  the  safety  and 
tolerability  via  frequency  and  severity  of  adverse  effects  of  combination  Gleevec™  and  gemcitabine 
in  this  cohort  of  subjects  as  assessed  by  CTC.  (4)  To  determine  the  distribution  of  the  overall 
survival.  (5)  To  estimate  the  clinical  response  rate  (partial  and  complete  response  as  defined  under 
the  modified  SWOG  criteria).  (6)  To  assess  the  effects  of  prognostic  variables:  initial  performance 
status,  platinum  sensitivity,  and  mucinous  (or  clear  cell)  histology  on  progression-free  survival 
overall. 

Technical  Approach:  This  is  a  Phase  II,  single  arm,  open  label  treatment  study  to  evaluate  the 
tumor  response  rate  to  the  combination  of  Gleevec  and  Gemcitabine  for  treatment  of  women  who 
have  failed  at  least  one  prior  chemotherapy  regimen  containing  platinum.  60  subjects  are  expected 
to  enroll  to  achieve  a  goal  of  56  evaluable  subjects,  with  20  subjects  expected  to  enroll  at  MAMC. 
Women  will  be  recruited  during  regular  visits  to  the  Oncology  Clinic;  those  appearing  eligible  will 
be  consented  and  screened.  Those  who  qualify  will  be  given  a  combination  of  oral  Gleevec  and  IV 
Gemcitabine,  over  a  21  day  cycle,  for  as  long  as  they  respond  and  are  able  to  tolerate  the 
combination.  Subjects  experiencing  side  effects  may  receive  supportive  care  with  growth  factors  or 
antiemetics  as  appropriate  or  have  their  dose  modified  per  protocol.  Subjects  will  be  followed  after 
each  cycle  by  physical  exams,  laboratory  assessments  including  CA-125  tumor  marker,  and  by 
review  of  adverse  events  and  cancer-related  symptoms.  Tumor  assessments  will  be  done  every 
other  cycle  by  CT  or  MRI.  Subjects  removed  from  treatment  will  be  followed  every  three  months 
by  clinic  visit  or  phone  contact  for  up  to  five  years  to  determine  time  to  progression  and  survival 
rates. 

Progress:  This  greater  than  minimal  risk  protocol  received  initial  approval  with  stipulations 
during  the  convened  IRB  meeting  on  26  September  2006. 


171 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204114 

Status:  Ongoing 

Title:  A  Phase  II  Trial  of  Weekly  Docetaxel  plus  Every  3-Week  Carboplatin 
Stage  IIIB/IV  Non-small  Cell  Lung  Cancer,  Protocol  GIA  12156 

in  Patients  with 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

10/27/2004  -  Nov  2007  Aventis  Pharmaceuticals,  Inc.  via  Henry  M. 

Jackson  Foundation 

Periodic  Review: 

8/29/2006 

Study  Objective:  Primary  Objective  is  to  determine  overall  response  rate  for  patients  with 
advanced  non-small  cell  lung  cancer  treated  with  weekly  docetaxel  35  mg/m2  on  days  1  and  8  plus 
carboplatin  (AUC  6)  on  day  1  every  21  days.  Secondary  Objectives  are  to  determine  the  1-year 
survival  rate,  the  median  overall  survival  rate,  and  to  evaluate  the  safety  and  toxicity  associated 
with  this  regimen. 

Technical  Approach:  This  trial  is  a  two- stage,  phase  II  study  of  weekly  docetaxel  35  mg/m2 
infused  on  days  1  and  8  plus  carboplatin  (AUC  6)  on  day  1  only,  repeated  every  21  days  (cycle)  in 
patients  with  stage  IIIB  or  IV  advanced  non  small  cell  lung  cancer  who  have  not  received  prior 
chemotherapy.  4-6  MAMC  subjects  are  expected  to  be  enrolled.  A  total  of  29  patients  may  be 
enrolled  in  the  study  overall.  Physical  examination  and  history,  baseline  tumor  assessments, 
ECOG  performance  status,  CBC,  serum  chemistry,  EKG,  and  serum  HCG  as  appropriate,  will  be 
evaluated  prior  to  study  treatment.  A  minimum  of  two  courses  of  treatment  will  be  given  unless 
there  is  progression  of  disease  or  significant  adverse  reactions  occur.  Patients  will  be  monitored 
after  every  two  cycles  (6  weeks)  for  tumor  response  using  standard  radiographic  imaging. 

Objective  response  will  be  evaluated  using  the  RECIST  criteria  (Response  Evaluation  Criteria  In 
Solid  Tumors).  Clinical  and  laboratory  toxicities  will  be  assessed  and  graded  according  to  the  NCI 
Common  Toxicity  Criteria,  version  2.0.  Appropriate  supportive  care  treatment  will  be 
administered.  Chemotherapy  dose  adjustments  will  be  made  based  on  the  organ  system  exhibiting 
the  greatest  degree  of  toxicity.  Eligible  patients  will  be  treated  for  2  additional  cycles  after  best 
documented  tumor  response.  All  patients  will  be  followed  after  treatment  at  defined  intervals  for 
survival  data. 

The  primary  endpoint  of  this  study  is  overall  response  rate  (complete  response  plus  partial 
response).  Ten  patients  will  be  enrolled  into  the  first  stage.  If  at  least  1  patient  responds,  19 
additional  patients  will  be  enrolled  into  the  second  stage  of  the  study.  If  at  least  5  of  29  evaluable 
patients  exhibit  an  objective  response  at  the  end  of  the  second  stage,  the  conclusion  will  be  that 
this  regimen  is  worthy  of  further  study.  Secondary  endpoints  will  be  reported  for  the  1-year 
survival  rate,  the  median  overall  survival  rate,  evaluations  of  safety  and  toxicity  associated  with 
this  regimen.  The  primary  efficacy  analysis  will  be  conducted  on  all  patients  who  receive  the  study 
drug.  Objective  tumor  response  rate  along  with  exact  95%  binomial  confidence  intervals  will  be 
calculated.  Time-to-event  outcomes  including  1-year  survival,  time  to  disease  progression,  and 
duration  of  response  will  be  estimated  using  the  Kaplan-  Meier  product  limit  method.  Median  and 
quartile  estimates  for  each  time-to-event  outcome  will  be  obtained  from  the  Kaplan-Meier 
estimates. 

Progress:  This  protocol  closed  to  enrollment  with  one  subject  enrolled  who  remains  in  follow-up 
for  survival  information  only.  There  are  no  unreported  serious  adverse  events  at  the  time  of  this 
report. 


172 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204006  Status:  Terminated 

Title:  A  Phase  III,  Randomized,  Double-blinded  Efficacy  and  Safety  Study  of  Three  Doses  of 
TAS-108  Administrated  Orally  in  Postmenopausal  Patients  with  Locally  Advanced  or  Locally 
Recurrent  Inoperable  or  Progressive  Metastatic  Breast  Carcinoma  Lollowing  Standard  Lirst 
Line  Endocrine  Therapy,  Protocol  Number  TAS 108-0004 


Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  M. 
Rick  Rutledge,  MS 

Start  -  Completion:  Funding: 

1/20/2004  -  Jan  2006  Taiho  Pharmaceutical  Co.,  Ltd.  via  Henry  M. 

Jackson  Foundation 

Periodic  Review: 

11/22/2005 

Study  Objective:  (1)  To  determine  the  efficacy  of  TAS-108  administered  orally  once  daily  at  40 
mg,  80  mg,  and  120  mg  in  postmenopausal  patients  with  locally  advanced  or  locally  recurrent 
inoperable  or  progressive  metastatic  ER/PgR  positive  breast  carcinoma  who  have  previously 
responded  to  a  standard  first  line  endocrine  therapy.  (2)  To  evaluate  the  safety  of  TAS-108 
administered  on  this  schedule.  (3)  To  investigate  the  comparative  concentrations  of  TAS-108  and 
its  metabolite  in  tumor  tissue  and  blood  at  steady-state.  (4)  To  determine  the  time  to  progression 
of  TAS-108  administered  on  this  schedule. 

Technical  Approach:  This  is  a  phase  II,  randomized,  double-blinded  study  of  TAS-108 
administered  orally  once  daily  at  40  mg,  80  mg,  or  120  mg  to  be  carried  out  at  multiple  study  sites. 
The  statistical  calculation  of  the  sample  size  will  be  based  on  a  single  arm  study  design  and  the 
study  will  use  this  same  number  for  each  dose  group.  It  is  exactly  the  same  as  three  identical 
studies,  using  40  mg,  80  mg,  and  120  mg  to  be  conducted  at  the  same  study  sites  at  the  same  time. 
The  efficacy  and  safety  results  from  each  dose  group  will  only  be  evaluated  independently  and 
clinically,  but  not  compared  biostatistically.  Patients  will  be  enrolled  to  the  40  mg,  80  mg,  and  120 
mg  dose  levels  randomly  until  the  first  stage  number  is  met  for  each  dose  group.  Depending  on  the 
randomization  schedule,  the  enrollment  completion  for  each  group  may  be  far  apart.  The 
enrollment  will  be  put  on  hold  for  each  respective  dose  group  until  the  data  to  be  evaluated  meets 
the  preset  criterion  to  proceed  to  the  second  stage.  Since  each  dose  group  will  be  evaluated 
separately  and  independently,  the  time  point  of  meeting  the  preset  criteria  and  allowing  patients 
to  proceed  into  the  second  stage  of  the  study  will  most  likely  be  different  for  the  three  dose  groups. 
When  the  enrollment  into  the  second  stage  of  the  study  for  each  dose  group  is  completed,  analysis 
for  each  group  will  be  performed  independently  according  to  the  analysis  plan.  In  this  study,  one 
course  equals  28  days  of  treatment.  Patients  will  receive  study  treatment  until  (a)  there  is 
evidence  of  disease  progression  or  (b)  the  patient  develops  unacceptable  toxicity  to  TAS-108  or  (c) 
the  patient  withdraws  informed  consent. 

Progress:  This  protocol  was  terminated  by  the  PI  in  July  2006,  with  no  subjects  enrolled.  Only 
one  patient  had  met  the  appropriate  inclusion  criteria,  but  she  decided  not  to  participate  in  the 
study. 


173 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204044  Status:  Ongoing 

Title:  A  Phase  III  Study  of  Delayed  vs.  Immediate  Second-line  Therapy  with  Docetaxel  after 
Gemcitabine  +  Carboplatin  in  Advanced  Non- Small  Cell  Lung  Cancer,  Protocol  Number  B9E- 
US-S245 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

4/1/2004  -  Apr  2007  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  Primary  Objective  is  to  test  the  value  in  terms  of  overall  survival  of  immediate 
sequential  therapy  with  docetaxel  compared  to  traditional  second-line  therapy  with  docetaxel  at 
the  time  of  progression  after  standard  Carboplatin  and  Gemcitabine  in  patients  with  stage  Illb 
and  IV  non-small  cell  lung  cancer.  Secondary  Objectives:  (1)  to  assess  the  response  rate  and  time 
to  disease  progression,  (2)  to  compare  toxicity  in  these  two  groups  and  (3)  to  compare  quality  of  life 
using  the  LCSS  patient  scale. 

Technical  Approach:  This  is  a  multicenter  open-label  randomized  phase  III  trial  to  evaluate  the 
respective  response  rates,  time  to  disease  progression,  survival  time,  toxicity,  and  quality  of  life  of 
immediate  sequential  therapy  with  docetaxel  compared  to  traditional  second-line  therapy  with 
docetaxel  at  the  time  of  disease  progression,  after  standard  Carboplatin  and  gemcitabine  in 
subjects  with  stage  Illb  and  IV  non- small  cell  lung  cancer  (NSCLC).  Up  to  5  MAMC  subjects  may 
participate,  with  550  subjects  in  the  overall  study.  Duration  of  individual  participation  will  be  up 
to  36  months.  The  study  will  enroll  chemotherapy-naive  subjects  whose  NSCLC  is  advanced  at 
diagnosis  or  has  recurred  or  progressed  following  surgical  treatment  and/or  radiation  therapy,  and 
who  meet  additional  eligibility  criteria. 

Following  screening,  eligible  subjects  will  receive  the  first  phase  of  treatment  with  gemcitabine 
and  Carboplatin  chemotherapy  on  Day  1  and  Day  8  every  21  days,  followed  by  one  week  of  rest,  for 
four  cycles.  Safety  and  response  will  be  monitored.  Disease  restaging  will  be  done  at  the  end  of 
first  phase  treatment.  Subjects  with  complete  or  partial  response  or  stable  disease  after  initial 
therapy  will  be  rescreened  and  eligible  subjects  will  be  randomized  (1:1)  to  the  second  phase 
treatment  with  immediate  or  delayed  docetaxel.  Subjects  found  to  have  progressive  disease  after 
initial  therapy  or  who  discontinue  prior  to  completion  of  4  cycles  will  be  followed  for  survival  data. 
Subjects  randomized  to  delayed  therapy  will  be  monitored  every  three  weeks  prior  to  treatment. 
Radiological  imaging  of  tumor  sites  will  be  performed  every  3  months  or  as  clinically  indicated. 
With  evidence  of  disease  progression,  subjects  begin  treatment  with  docetaxel.  Subjects 
randomized  to  receive  immediate  sequential  docetaxel  and  subjects  initiating  traditional 
treatment  after  progression  will  receive  docetaxel  on  Day  1  every  3  weeks  for  a  maximum  of  6 
cycles.  Response  and  safety  will  be  monitored.  Subjects  who  complete  the  protocol  or  who 
discontinue  study  chemotherapy  early  will  be  followed  at  protocol  intervals  until  progression  or 
death.  The  primary  endpoint  is  survival  and  will  be  measured  from  time  of  randomization  to  date 
of  death  for  all  randomized  subjects.  Secondary  endpoints  of  response  rates,  time  to  progression, 
toxicity,  and  LCSS  will  be  compared  between  regimens.  An  independent  Data  Safety  Monitoring 
Board  will  assess  safety  at  the  time  of  formal  interim  analysis,  planned  when  50%  of  subjects  in 
each  docetaxel  treatment  arm  have  1)  died,  2)  are  lost  to  follow  up  prior  to  24  months,  or  3)  have 
been  followed  up  for  at  least  24  months. 

Progress:  This  protocol  closed  to  enrollment  with  seven  subjects  consented.  Five  subjects  are 
deceased  due  to  non-study  related  deaths  and  two  patients  continued  to  be  followed  during  FY06. 


174 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204096  Status:  Completed 

Title:  A  Randomized,  Open-Label  Study  of  PROCRIT®  (Epoetin  Alfa)  Initiated  at  40,000  Units 
Every  Week  Versus  80,000  Units  Every  Two  Weeks  In  Anemic  Patients  With  Cancer  Receiving 
Chemotherapy,  Protocol  PR03-27-064 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

9/15/2004  -  Sep  2006  OrthoBiotech  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

6/28/2005 

Study  Objective:  Primary  Objective:  To  compare  end  of  study  hemoglobin  (Hb)  levels  of  subjects 
receiving  epoetin  alfa  (PROCRIT®)  40,000  units  administered  subcutaneously  once  every  week 
with  those  receiving  80,000  units  every  two  weeks,  in  anemic  patients  with  cancer  diagnosis  and 
receiving  chemotherapy.  Secondary  Objectives:  To  assess  Hb  response,  time  to  Hb  response, 
transfusion  requirements,  and  safety  of  the  two  dose  regimens. 

Technical  Approach:  This  is  a  randomized,  open-label,  multi-center  trial  that  will  compare 
efficacy  and  safety  of  two  dose  regimens  of  Procrit®  (Epoetin  Alfa),  40,000  units  administered 
subcutaneously  once  every  week  with  80,000  units  every  two  weeks,  in  anemic  patients  with  non- 
myeloid  cancer  diagnosis  and  receiving  chemotherapy.  280  patients  who  meet  all  inclusion  and 
exclusion  criteria  will  be  enrolled  and  randomized  at  approximately  75  study  centers  to  one  of  the 
two  treatment  groups  in  a  1:1  ratio.  The  enrollment  phase  is  expected  to  last  15  months.  All 
patients  will  be  followed  weekly  until  two  weeks  after  the  last  dose  of  Epoetin  Alfa,  or  up  to  a 
maximum  of  13  weeks  on  study  (12  weeks  of  study  drug).  The  starting  doses  may  be  adjusted  per 
protocol  based  on  Hb  response.  If  chemotherapy  is  completed  before  week  12,  one  final  dose  of 
Epoetin  Alfa  will  be  administered  on  the  assigned  schedule  at  the  end  of  the  final  cycle  of 
chemotherapy.  Unless  there  is  a  contraindication,  all  patients  will  receive  iron  supplementation 
(ferrous  sulfate  325mg  by  mouth  daily  or  an  equivalent).  Transfusions  may  occur  as  needed  for 
patient  care.  At  MAMC,  a  hemoglobin  value  of  less  than  8.0  g/dL  or  a  clinical  judgment  based  on 
symptoms  will  be  the  trigger  event  for  blood  transfusion.  Subjects  will  be  monitored  weekly 
during  treatment  and  at  study  completion  for  blood  pressure,  hematologic  response  (hemoglobin 
and  hematocrit),  adverse  events,  concomitant  medications  and  transfusions.  Physical  exam  with 
vital  signs,  ECOG  Performance  Status,  and  laboratory  testing  as  completed  at  screening  will  be 
repeated  at  the  end  of  study.  The  primary  efficacy  endpoint  is  end  of  study  Hb,  which  will  be 
analyzed  for  the  per-protocol  and  intent  to  treat  populations.  Safety  analyses  will  describe  adverse 
events,  laboratory  values,  physical  exam,  vital  signs  and  ECOG  status  and  will  include  all 
randomized  subjects  receiving  at  least  one  dose  of  study  medication. 

Progress:  This  protocol  closed  to  enrollment  16  May  05,  and  closed  as  a  study  site  22  November 
2006,  with  eight  subjects  screened,  two  screen  failures,  six  enrolled,  four  completed  the  study,  one 
was  removed  when  relocated,  and  one  subject  removed  for  what  was  thought  to  be  a  thrombosis, 
which  turned  out  not  to  be  so  and  was  not  reported  as  an  event.  No  internal  serious  adverse  events 
were  reports. 


175 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202083  Status:  Ongoing 

Title:  A  Randomized  Phase  III  Trial  of  Gemzar  versus  Doxil  with  Crossover  Treatment  Option 
for  Patients  with  Platinum-Resistant  Ovarian,  Fallopian  Tube  or  Primary  Peritoneal  Cancer 
Undergoing  Second  or  Third-Line  Chemotherapy,  Protocol  Number:  B9E-US-S301 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

8/14/2002  -  Jul  2005  Lilly  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

5/22/2006 

Study  Objective:  (1)  To  compare  progression  free  survival  in  patients  with  platinum-refractory 
epithelial  ovarian,  Fallopian  tube,  or  primary  peritoneal  carcinoma  who  have  failed  two  or  less 
prior  regimens  of  chemotherapy  that  are  treated  with  Doxil  or  Gemzar.  (2)  To  compare  response 
rate,  duration  of  response,  time  to  treatment  failure,  survival,  and  quality  of  life  in  patients  with 
platinum-refractory  epithelial  ovarian,  Fallopian  tube,  or  primary  peritoneal  carcinoma  who  have 
failed  two  or  less  prior  regimens  of  chemotherapy  who  are  treated  with  Doxil  or  Gemzar. 

Technical  Approach:  At  MAMC  there  are  expected  to  be  5-10  patients  enrolled  during 
approximately  one  year. 

Patient  screening  will  include  written  informed  consent,  medical  history  and  demographics,  tumor 
assessment  by  exam  or  imaging,  FACT-0  questionnaire,  Zubrod  Performance  Status,  LVEF, 
chemistry  and  hematology,  CA-125  tumor  marker,  contraceptive  status  and  serum  pregnancy  test. 
Patients  on  the  Doxil  arm  will  be  treated  with  50  mg/m2  on  Day  1  of  each  28  day  cycle.  Treatment 
will  continue  for  two  cycles  after  a  complete  response,  or  until  a  cumulative  maximum  dose  of  500 
mg/m2  has  been  given.  Patients  on  the  Gemzar  arm  will  be  treated  with  1000mg/m2  on  Days  1 
and  8  of  a  21  day  cycle.  Treatment  will  continue  for  up  to  two  cycles  after  complete  response  is 
attained.  For  patients  with  stable  disease  there  is  no  maximum  number  of  Gemzar  cycles.  Patients 
who  have  progressive  disease  may  cross  over  to  the  other  treatment  arm  if  they  are  eligible. 
Patients  will  be  monitored  every  cycle  for  toxicities,  chemistry,  hematology,  performance  status 
and  CA-125  tumor  staging.  Dose  adjustments  will  be  made  based  on  NCI  toxicity  criteria.  FACT- 
O  Quality  of  Life  questionnaire  will  be  administered  every  other  cycle,  and  tumor  assessment 
imaging  will  be  performed  every  12  weeks.  Primary  efficacy  will  be  evaluated  using  Kaplan-Meier 
techniques.  Secondary  efficacy  analysis  will  be  conducted  on  response  rate,  duration  of  response, 
time  to  treatment  failure,  survival  and  quality  of  life.  Response  rates  from  the  two  treatment 
arms  will  be  compared  using  Fisher's  Exact  test.  Summaries  on  toxicity  parameters  will  be 
provided. 

Progress:  This  protocol  closed  to  patient  entry  in  May  2004,  with  four  patients  enrolled.  Two 
patients  are  deceased  and  two  continued  to  be  followed  at  MAMC  during  FY06.  No  patients  are 
receiving  treatment.  The  protocol  remains  ongoing  pending  closeout  of  the  database  by  the  study 
sponsor. 


176 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204107  Status:  Suspended 

Title:  CTSU  ACOSOG-Z9001,  A  Phase  III  Randomized  Double-blind  Study  of  Adjuvant  STI571 
(Gleevec™)  Versus  Placebo  in  Patients  Following  the  Resection  of  Primary  Gastrointestinal 
Stromal  Tumor  (GIST) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

11/1/2004  -  Aug  2008  ACOSOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

12/12/2006 

Study  Objective:  Primary  Objective:  To  ascertain  whether  patients  with  resected  primary  GIST 
who  are  randomized  to  the  ST1571  Arm  have  longer  recurrence-free  survival  as  compared  to  the 
patients  randomized  to  the  Placebo  Arm.  Secondary  Objectives:  (1)  To  ascertain  whether  patients 
with  resected  primary  GIST  who  are  randomized  to  the  STI571  Arm  have  longer  survival  as 
compared  to  the  patients  randomized  to  the  Placebo  Arm.  (2)  To  obtain  from  patients  with  GIST: 
tumor  tissue  (before  therapy  with  ST1571  and  if  the  patient  develops  recurrence),  blood  specimens 
(before  therapy  with  STI571),  and  serum  specimens  (before  therapy  with  ST1571,  after  completing 
therapy  with  ST1571,  and  if  the  patient  develops  recurrence)  for  scientific  correlative  analyses.  (3) 
To  assess  the  safety/efficacy  of  oral  ST1571  therapy  in  the  adjuvant  setting. 

Technical  Approach:  Patients  will  be  randomized  into  one  of  two  groups;  four  lOOmg  capsules 
for  a  total  of  400mg  of  the  experimental  drug  or  placebo  by  mouth  every  day  for  1  year.  Weight 
should  be  measured  at  home  two  times  per  week  and  the  physician  called  if  there  is  a  weight 
change  by  more  than  4  pounds  from  the  weight  taken  at  the  last  clinic  visit.  Patients  will  have  a 
physical  exam  before  the  start  of  drug  or  placebo  and  then  seen  in  the  clinic  weekly  the  first  2 
weeks,  at  weeks  4,  6  and  8,  at  3,  4,  5  and  6  months,  every  3  months  until  year  2,  every  6  months 
until  year  5  and  then  every  year  until  death. 

Tumor  tissue  will  be  sent  to  a  central  pathologist  to  confirm  the  diagnosis  of  GIST  and  if  it  has  a 
protein  called  Kit,  as  the  presence  of  this  protein  is  required  for  the  Gleevec  to  work.  If  the  tissue 
sample  results  show  that  the  tumor  is  not  GIST  or  if  the  Kit  protein  is  not  there,  the  study  drug 
will  be  stopped  and  patients  will  have  a  physical  examination  and  a  blood  test  about  30  days  after 
the  study  drug  is  stopped.  These  patients  will  continue  to  be  contacted  by  phone  every  3  months 
for  1  year,  every  6  months  for  3  years,  and  then  every  year  until  death. 

Progress:  This  protocol  remains  open  to  enrollment,  with  one  subject  enrolled  and  remained  on 
active  treatment  during  FY06. 


177 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202114  Status:  Ongoing 

Title:  CTSU  CALGB  40101,  Cyclophosphamide  and  Doxorubicin  (CA)  (4  VS  6  Cycles)  versus 
Paclitaxel  (4  VS  6  Cycles)  as  Adjuvant  Therapy  for  Women  with  0-3  Positive  Axillary  Lymph 
Nodes:  A  2X2  Factorial  Phase  III  Randomized  Study 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/14/2002  -  Oct  2005  SWOG  via  Henry  M.  Jackson  Foundation  8/22/2006 

Study  Objective:  Primary  Objectives:  (1)  To  determine  the  equivalence  of  paclitaxel  given  every 
two  weeks  with  CA  given  every  two  weeks  as  adjuvant  therapy  for  women  with  0-3  positive 
axillary  lymph  nodes,  for  disease  free  survival.  (2)  To  determine  if  longer  therapy,  12  weeks,  is 
superior  to  shorter  therapy,  8  weeks,  of  either  CA  or  paclitaxel  for  disease-free  survival  for  women 
with  primary  breast  cancer  with  0-3  positive  axillary  lymph  nodes. 

Secondary  Objectives:  (1)  To  determine  the  equivalence  of  paclitaxel  given  every  two  weeks  with 
CA  given  every  two  weeks,  and  the  potential  superiority  of  longer  vs.  shorter  therapy,  in  relation 
to  overall  survival,  local  control  (regardless  of  metastatic  status)  and  time  to  distant  metastases 
(regardless  of  local  recurrence  status  (2)  Compare  toxicities  of  short  and  long  course  CA  and 
paclitaxel  as  adjuvant  therapy  for  women  with  0-3  positive  axillary  lymph  node  breast  cancer  (3) 

To  determine  the  effect  of  long  and  short  course  CA  and  paclitaxel  on  the  induction  of  menopause 
for  pre-menopausal  patients.  (4)  To  assess  the  discrepancy  of  myelosuppression  among  the 
common  MDR1  haplotypes  in  the  CA  treatment  arm.  (5)  To  assess  the  effect  of  MDR1  haplotypes 
on  DFS  adjusted  for  treatment.  (6)  Exploratory  analysis  of  the  effect  of  CYP3A5,  CYP2Cs  and 
CYP2B6  polymorphisms  on  DFS  and  toxicity. 

Technical  Approach:  This  is  a  randomized  study  and  patients  will  be  stratified  according  to 
menopausal  status  (premenopausal  vs  postmenopausal)  and  estrogen  receptor  (ER)/progesterone 
receptor  (PR)  status  (ER  and/or  PR  positive  or  unknown  vs  ER  and  PR  negative).  Patients  are 
randomized  to  1  of  4  treatment  arms.  Arm  I:  Patients  receive  doxorubicin  IV  over  10-15  minutes 
and  cyclophosphamide  IV  on  day  1.  Treatment  repeats  every  21  days  for  4  courses.  Arm  II: 

Patients  receive  doxorubicin  and  cyclophosphamide  as  in  arm  I.  Treatment  repeats  every  21  days 
for  6  courses.  Arm  III:  Patients  receive  paclitaxel  IV  over  1  hour  once  weekly  for  12  weeks.  Arm  IV: 
Patients  receive  paclitaxel  as  in  arm  III  for  18  weeks.  Treatment  in  all  arms  continues  in  the 
absence  of  disease  progression  or  unacceptable  toxicity.  Lumpectomy  patients  must  then  undergo 
radiotherapy.  Mastectomy  patients  undergo  radiotherapy  at  the  discretion  of  the  treating 
physician.  Patients  are  followed  every  6  months  for  2  years  and  then  annually  for  15  years. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  six  patients  enrolled.  One  patient  is 
currently  receiving  active  treatment  and  the  other  five  continued  to  be  followed  at  MAMC  during 
FY06. 


178 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202089  Status:  Ongoing 

Title:  CTSU  CALGB  49907,  A  Randomized  Trial  of  Adjuvant  Chemotherapy  With  Standard 
Regimens,  Cyclophosphamide,  Methotrexate  and  Fluorouracil  -  (CMF)  or  Doxorubicin  and 
Cyclophosphamide  -  (AC),  Versus  Capecitabine  in  Women  65  Years  and  Older  with  Node 
Positive  or  Node  Negative  Breast  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/5/2002  -  Jul  2005  SWOG  via  Henry  M.  Jackson  Foundation  5/22/2006 

Study  Objective:  (1)  To  compare  the  effectiveness  of  standard  chemotherapy  (CMF  or  AC)  with 
single  agent  Capecitabine  with  respect  to  disease-free  survival  in  women  65  years  and  older  with 
local  and  regional  breast  cancer.  (2)  To  compare  the  effectiveness  of  standard  chemotherapy 
regimens  with  Capecitabine  with  respect  to  overall  survival. (3)  To  determine  the  effects  of  each 
treatment  regimen  on  quality  of  life  and  physical  function.  (4)  To  assess  the  toxicity  of  each 
treatment  program.  (5)  To  study  the  adherence  to  an  oral  chemotherapy  regimen  in  older  patients. 

Technical  Approach:  This  study  compares  the  oral  anti-cancer  drug  Capecitabine  to  standard 
adjuvant  therapy  of  Cyclophosphamide,  Methotrexate  and  Fluorouracil,  or  Doxorubicin  and 
Cyclophosphamide  in  women  who  have  complete  breast  cancer  surgery  and  are  over  65  years  old. 
The  study  will  attempt  to  find  a  survival  her  forth  difference  in  relapse  rates  or  a  quality  of  life. 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled. 


179 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204124  Status:  Completed 

Title:  CTSU  CALGB  80303,  A  Randomized  Phase  III  Trial  of  Gemcitabine  plus  Bevacizumab 
(NSC  #704865  IND  #7921)  Versus  Gemcitabine  plus  Placebo  in  Patients  With  Advanced 
Pancreatic  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

1/25/2005  -  Oct  2008  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

8/19/2005 

Study  Objective:  The  primary  objective  is  to  determine  if  combination  chemotherapy  with 
Gemcitabine  and  Bevacizumab  achieves  superior  survival  compared  to  Gemcitabine  and  Placebo  in 
patients  with  previously  untreated  advanced  pancreatic  cancer.  Secondary  objective  is  to  compare 
response  rates,  duration  of  response,  progression  free  survival,  and  toxicity  of  these  two  regimens 
in  patients  with  advanced  pancreatic  cancer.  Angiogenic  biomarker  studies  are  to  measure 
baseline  levels  of  VEGF  and  correlate  with  treatment  outcome,  to  measure  baseline  and  on 
treatment  levels  of  additional  growth  factors  that  may  be  co-  or  counter-regulated  with  VEGF  and 
correlate  with  response  to  treatment,  to  measure  baseline  and  treatment  levels  of  coagulation  and 
endothelial  cell  activation  markers  and  to  generate  protein  expression  profiles  using  a  MALDI- 
TOF  based  platform  from  serum  samples.  Pharmacogenomic  predictors  outcome  is  to  assess  any 
differences  in  overall  survival  within  the  treatment  arm  (Gemcitabine+Bevacizumab),  between  the 
two  VEGF  genotypic  groups:  Group  I  denoted  by  individuals  with  CT  or  TT  genotypes  and  Group  2 
consisting  of  individuals  with  CC  genotypes.,  to  conduct  an  exploratory  analysis  of  gene-toxicity, 
gene-response,  and  gene  survival  relationships.  The  clinical  Economics  of  the  study  is  to  compare 
the  effects  of  Gemcitabine+Bevacizumab  versus  Gemcitabine+  Placebo  on  resource  utilization, 
cost,  and  utilities,  and  if  applicable,  to  make  estimates  of  marginal  cost-utility. 

Technical  Approach:  This  study  compares  standard  gemcitabine  chemotherapy  for  advanced 
pancreatic  cancer  to  standard  therapy  plus  Bevacizumab,  a  monoclonal  antibody  directed  at 
vascular  endothelial  growth  factor.  Eligible  patients  will  be  randomized  to  receive  either 
Gemcitabine  plus  Bevacizumab  or  Gemcitabine  plus  placebo.  Each  treatment  group  receives 
therapy  over  a  28  day  cycle.  The  study  will  compare  response  rates,  toxicity  and  survival  between 
the  two  treatments  in  an  attempt  to  establish  a  new  standard  of  care. 

Progress:  The  protocol  was  reported  completed  at  MAMC  in  April  2006  when  the  study  closed  to 
enrollment  with  one  subject  who  enrolled  during  FY05,  but  died  due  to  disease  progression. 


180 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202088  Status:  Ongoing 

Title:  CTSU  E1A00  A  Randomized  Phase  III  Trial  of  Thalidomide  (NSC  #66847)  Plus 
Dexamethasone  versus  Dexamethasone  in  Newly  Diagnosed  Multiple  Myeloma 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/25/2002  -  Jul  2005  SWOG  via  Henry  M.  Jackson  Foundation  5/22/2006 

Study  Objective:  1)  To  evaluate  the  response  rate  and  toxicity  of  thalidomide  plus  dexamthasone 
and  dexamethasone  alone  in  patients  with  newly  diagnosed  myeloma.  2)  To  study  the  effect  of 
thalidomide  on  bone  marrow  microvessel  density  and  angiogenesis  grade  and  on  the  expression  of 
vascular  endothelial  growth  factor  (VEGF)  and  basic  fibroblast  growth  factor  (bFGF)  in  the 
marrow. 

Technical  Approach:  Compare  a  standard  treatment  for  myeloma,  dexamethasone  to 
dexamethasone  plus  thalidomide.  The  goal  of  the  study  is  to  see  if  there  is  any  difference  between 
the  two  with  respect  to  response  rate,  complications  and  quality  of  life  or  survival. 

Progress:  This  protocol  closed  to  patient  entry  in  April  2003,  with  one  patient  enrolled  who 
continued  to  be  followed  at  MAMC  during  FY06. 


181 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204072  Status:  Completed 

Title:  CTSU  E3201  Intergroup  Randomized  Phase  III  Study  of  Postoperative  Irinotecan,  5- 
Fluorouracil  and  Leucovorin  vs  Oxaliplatin,  5-Fluorouracil  and  Leucovorin  vs  5-Fluorouracil  and 
Leucovorin  for  Patients  with  Stage  II  or  III  Rectal  Cancer  Receiving  Either  Preoperative 
Radiation  and  5-Fluorouracil  or  Postoperative  Radiation  and  5-Fluorouracil 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  Tommy  A.  Brown,  MC;  MAJ 
Jasmine  T.  Daniels,  MC;  LTC  William  B.  Reece,  MC;  LTC  John  B.  Halligan,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/2/2004  -  May  2008  SWOG  via  Henry  M.  Jackson  Foundation  4/25/2005 

Study  Objective:  (1)  To  compare  the  overall  survival  of  patients  treated  with  Irinotecan,  5-FU 
and  Leucovorin  versus  those  treated  with  Oxaliplatin,  Leucovorin  and  5-UF  versus  those  treated 
with  Leucovorin  and  5-FU  for  patients  with  Stage  II  and  III  rectal  cancer.  (2)  To  compare 
sphincter  preservation,  tolerance  of  treatment  and  patterns  of  failure.  (3)  To  prospectively  assess 
rectal  function  using  the  Patient  Bowel  Function/Uniscale  questionnaire  and  the  FACT  Diarrhea 
Subscale  in  patients  treated  with  an  adjuvant  program  of  pelvic  radiation  therapy  and 
chemotherapy.  (4)  To  correlate  TS<  DPD  and  TP  expression  (key  targets  for  5-FU);  retention  of 
chromosome  18q  alleles  and  MSI  with  TGF131RII  mutation)  (markers  for  5-FU  efficacy);  and  p53 
gene  mutation  in  tumor  tissue  specimens  with  treatment  efficacy  (5)  To  correlate  tumor  molecular 
prognostic  markers  (chromosome  18q  allelic  loss  and  MSI)  with  survival.  (6)  To  determine 
physician  preference  in  regard  to  the  radiation-chemotherapy  sequence  in  the  Intergroup. 

Technical  Approach:  The  study  compares  standard  adjuvant  treatment  for  rectal  cancer  to  two 
different  chemotherapy  combinations  to  see  if  any  regimen  is  superior  for  survival  or  toxicities.  All 
eligible  patients  with  rectal  cancer  will  be  offered  the  study.  Subjects  will  be  offered  one  of  three 
chemotherapy  combinations:  (1)  5-FU  +  Leucovorin,  (2)  5-FU  +  Leucovorin  +  Oxaliplatin,  or  (3)  5- 
FU  +  Leucovorin  +  Irinotecan.  Data  will  be  collected  on  survival,  toxicity,  and  relapse  rates. 
Toxicity  will  be  assessed  at  each  patient  visit.  Data  will  be  analyzed  centrally  by  CTSU. 

Progress:  ECOG  announced  permanent  closure  of  this  protocol  effective  28  October  2005,  no 
patients  enrolled  at  MAMC.  This  study  has  been  redesigned  and  will  soon  open  with  a  new  study 
number  for  new  patient  accrual. 


182 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204043  Status:  Ongoing 

Title:  CTSU  IBCSG  Trial  25-02,  Tamoxifen  and  Exemestane  Trial  (TEXT),  A  Phase  III  Trial 
Evaluating  the  Role  of  Exemestane  Plus  GnRH  Analogue  as  Adjuvant  Therapy  for 
Premenopausal  Women  with  Endocrine  Responsive  Breast  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC;  LTC 
Tommy  A.  Brown,  MC;  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/12/2004  -  Feb  2009  SWOG  via  Henry  M.  Jackson  Foundation  1/24/2006 

Study  Objective:  Evaluate  the  worth  of  ovarian  function  suppression  (achieved  by  long-term  use 
of  GnRH  analogue)  plus  exemestane  compared  with  Groh  analogue  plus  Tamoxifen  for 
premenopausal  women  with  steroid  hormone  receptor-positive  early  invasive  breast  cancer. 

Technical  Approach:  This  trial  compares  two  different  types  of  hormonal  therapy  for  the 
prevention  of  relapse  after  breast  cancer  surgery.  Subjects  may  either  receive  no  chemotherapy  or 
commence  chemotherapy  at  the  same  time  that  GnRH  analogue  is  initiated.  Eligible  subjects  will 
be  randomized  into  one  of  two  groups;  surgery  plus  GnRH  analogue  and  tamoxifen  for  5  years  or 
surgery  plus  GnRH  analogue  plus  exemestane  for  5  years. 

Progress:  This  protocol  remains  open  to  enrollment  with  one  subject  enrolled  at  MAMC,  but  had 
to  be  transferred  to  Swedish  Hospital  and  Medical  Center,  Seattle,  WA. 


183 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204035  Status:  Ongoing 

Title:  CTSU  NCIC  CTG  MA.27,  A  Randomized  Phase  III  Trial  of  Exemestane  Versus 
Anastrozole  in  Postmenopausal  Women  With  Receptor  Positive  Primary  Breast  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/12/2004  -  Jan  2010  SWOG  via  Henry  M.  Jackson  Foundation  1/24/2006 

Study  Objective:  Primary  objective:  Compare  event  free  survival  (EFS)  between  women  treated 
with  exemestane  or  Anastrozole  as  adjuvant  therapy.  Secondary  objectives:  (1)  To  compare  overall 
survival(OS)  of  women  treated  with  exemestane  with  that  of  those  receiving  Anastrozole  as 
adjuvant  therapy,  (2)  To  compare  the  time  to  distant  recurrence  for  women  treated  with 
exemestane  with  that  for  women  receiving  Anastrozole  as  adjuvant  therapy,  (3)  To  compare  the 
incidence  of  new  primary  contra  lateral  breast  cancer  in  the  different  treatment  groups,  (4)  To 
compare  the  incidence  of  all  clinical  fractures  and  specifically  hip  and  vertebral  fractures  in  the 
different  treatment  groups,  and  (5)  To  compare  cardiovascular  morbidity  and  morality  (i.e. 
significant  coronary  heart  disease,  which  includes  myocardial  infarctions  and  angina  requiring 
percutaneous  transluminal  coronary  angioplasty  or  coronary  artery  bypass  graft,  fatal  and 
nonfatal  strokes  and  all  vascular  deaths)  between  exemestane  and  Anastrozole. 

Note:  Study  objectives  looking  at  the  use  of  Celecoxib  in  this  patient  population  were  discontinued, 
17  Dec.  04. 

Technical  Approach:  This  study  compares  two  different  aromatase  inhibitors  in  an  atempt  to 
establish  standard  of  care  for  this  type  of  breast  cancer.  Eligible  subjects  will  be  randomized  to 
receive  either  Exemestane  or  Anastrozole.  reatment  period  will  be  5  years  except  in  cases  of 
unacceptable  side  effects  or  disease  recurrence. 

Note:  The  randomization  in  a  double-blinded  fashion  to  receive  either  Celecoxib  or  placebo  was 
discontinued  Dec  04,  due  to  increased  frequency  of  fatal  and  non-fatal  cardiovascular  events 
observed  on  the  celecoxib  arm  of  an  NCI  sponsored  study  of  the  prevention  of  colorectal  polyps, 
ntioned  protocol  has  discontinued  giving  celecoxib/placebo  to  enrolled  subjects,  due  to  concerns 
about  the  use  of  the  Cox  II  inhibitor. 

Progress:  This  protocol  is  closed  to  enrollment  except  for  some  sites  that  are  performing  specific 
sub-studies.  Ten  patients  enrolled  at  MAMC,  and  remain  in  treatment  or  follow-up  during  FY06. 


184 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205071  Status:  Terminated 

Title:  CTSU  NSABP  80101  Phase  III  Intergroup  Trial  of  Adjuvant  Chemoradiation  after 

Resection  of  Gastric  or  Gastroesophageal  Adenocarcinoma 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  LTC  William  B.  Reece,  MC;  LTC 

John  B.  Halligan,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

Never  approved  SWOG  via  Henry  M.  Jackson  Foundation  N/A 

Study  Objective:  Primary  objective:  To  determine  whether  overall  survival  is  prolonged  in 
patients  with  resected  gastric  Adenocarcinoma  who  receive  epirubicin,  cisplatin,  and  infusional  5- 
FU  (ECF)  before  and  after  infusional  5-FU  plus  radiotherapy  (RT)  when  compared  to  those  treated 
with  bolus  5-FU  and  Leucovorin  before  and  after  infusional  5-FU  plus  RT.  Secondary  objectives. 

(1)  To  determine  disease-free  survival  and  distant  recurrence  rates  (2)  To  prospectively  assess 
whether  expression  of  putative  prognostic  markers  in  the  tumor  correlate  with  overall  survival  (3) 
To  prospectively  assess  whether  specific  germ  line  polymorphisms  related  to  chemotherapy 
metabolism  and  resistance  correlated  with  treatment-related  toxicity  and  overall  survival  (4)  To 
prospectively  assess  whether  serum  levels  of  various  growth  factors  correlated  with  overall 
survival  (5)  To  determine  whether  hospital  procedure  volume  predicts  recurrence-free  and  overall 
survival 

Technical  Approach: 

This  is  a  randomized  comparison  of  patients  with  completely  resected  gastric  or  gastroesophageal 
cancer  who  receive  ECF  before  and  after  infusional  5-FU  plus  RT  versus  patients  who  treated  with 
bolus  5-FU  and  Leucovorin  before  and  after  infusional  5-FU  plus  RT.  The  study  will  enroll  824 
patients,  male  and  female,  age  18  and  over,  who  have  undergone  complete  resection  of 
adenocarcinoma  of  the  stomach  or  gastroesophageal  junction.  Up  to  10  patients  will  participate  at 
MAMC.  Patients  will  be  assessed  at  screening  with  history  and  physical  exam,  height,  weight, 
vitals,  laboratory  tests  including  hematology,  chemistry  and  liver  functions,  CT  of  the  abdomen 
and  pelvis,  and  chest  x-ray  if  indicated.  Women  of  child-bearing  potential  will  have  a  serum 
pregnancy  test.  A  laboratory  sample  (4.5  ml  of  blood)  will  also  be  drawn  for  patients  participating 
in  the  60201  sub-study. 

For  patients  enrolled  in  Arm  A  (5-FU,  Leucovorin)  all  laboratory  tests  will  be  performed 
weekly  for  each  cycle  of  5-FU  and  Leucovorin  (cycles  1,  3  and  4)  and  weekly  during  RT  (cycle  2). 

For  patients  enrolled  in  Arm  B  (EPC,  5-FU)  all  laboratory  tests  will  be  performed  weekly  during 
radiation  therapy  and  weekly  during  chemotherapy  cycles.  Patients  will  also  be  followed  during 
treatment  with  physical  exam  at  the  beginning  of  each  cycle,  including  vital  signs,  weight,  and 
toxicity  assessment.  After  treatment  is  completed,  physical  exam  including  vital  signs,  weight  and 
laboratory  tests  will  be  repeated  every  3  months  for  2  years,  every  4  months  for  2  years,  then 
yearly  for  3  years  (7  years  total).  Disease  progression  will  be  assessed  by  chest  x-ray  as  indicated, 
at  week  30  then  yearly  for  5  years,  and  at  time  of  initial  tumor  progression. 

Patients  will  be  provided  with  nutritional  counseling,  and  monitored  for  weight  loss 
throughout  the  treatment  portion  of  the  study.  Weight  loss  of  >  5%  of  pretreatment  weight  will 
trigger  mandatory  intervention  such  as  oral  supplements,  nasal-intestinal  feeding  tubes, 
jejunostomy  and  intravenous  alimentation  depending  on  the  needs  of  the  patient. 

Progress:  This  protocol  received  initial  IRB  approval,  26  Apr  05,  but  was  administratively 
terminated  by  the  IRB  prior  to  final  approval  in  October  2005,  for  failure  to  comply  with  IRB 
stipulations. 


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Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202043 

Status:  Ongoing 

Title:  CTSU  RTOG  98-04:  Phase  III  Trial  of  Observation  +/-  Tamoxifen  vs. 
Good  Risk  Duct  Carcinoma  In-Situ  (DCIS)  of  the  Female  Breast 

RT  +/-  Tamoxifen  for 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC;  LTC 
Tommy  A.  Brown,  MC 

Start  -  Completion:  Funding: 

2/26/2002  -  Feb  2005  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  (1)  Comparing  whole  breast  radiation  +/-  Tamoxifen  compared  to  wide  excision 
to  negative  margins  alone  +/-  Tamoxifen,  in  decreasing  or  delaying  the  appearance  of  local  failure, 
both  invasive  and  in  situ,  and  preventing  need  for  mastectomy,  (2)  assess  distant  disease  free 
survival  patients  in  either  arm  who  fail  with  progression  can  be  successfully  salvaged  with  further 
definitive  local  therapy  and  adjuvant  systemic  therapy,  (3)  setting  up  a  working  pathology 
classification  system  for  DECIS,  (4)  establishing  an  epidemiological  questionnaire  registry  for 
companion  studies  of  biomarkers,  and  (5)  establish  tissue  bank  of  patients  who  progress  to  local 
failure  in  study  breast. 

Technical  Approach:  To  compare  the  efficacy  of  Tamoxifen  with  or  without  whole  breast 
radiation,  in  decreasing  or  delaying  the  appearance  of  local  failure,  both  invasive  and  in- situ,  and 
preventing  the  need  for  mastectomy  in  women  with  ductal  carcinoma  in-situ  (DCIS)  of  the  breast. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  no  patients  enrolled. 


186 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206112  Status:  Ongoing 

Title:  CTSU/GOG  0218  A  Phase  III  Trial  of  Carboplatin  and  Paclitaxel  Plus  Placebo  Versus 
Carboplatin  and  Paclitaxel  Plus  Concurrent  Bevacizumab  (NSC  #704865,  IND  #7921)  Followed 
By  Placebo,  Versus  Carboplatin  and  Paclitaxel  Plus  Concurrent  and  Extended  Bevacizumab,  In 
Women  With  Newly  Diagnosed,  Previously  Untreated,  Suboptimal  Advanced  Stage  Epithelial 
Ovarian  and  Primary  Peritoneal  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC;  LTC 
Louis  A.  Dainty,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/2/2006  -  Sep  2011  SWOG  via  Henry  M.  Jackson  Foundation  N/A 

Study  Objective:  Primary  objectives:  Determine  if  the  addition  of  5  concurrent  cycles  of 
Bevacizumab  to  6  cycles  of  standard  treatment  (carboplatin  and  paclitaxel)  [Arm  II]  reduces  the 
death  rate  when  compared  to  6  cycles  of  standard  treatment  alone  [Arm  I]  in  women  with  newly 
diagnosed  suboptimal  advanced  epithelial  ovarian  and  peritoneal  primary  cancer;  determine  if  the 
addition  of  5  concurrent  cycles  plus  extended  Bevacizumab  for  15  months  total  treatment  time  to  6 
cycles  of  standard  therapy  (carboplatin  and  paclitaxel)  [Arm  III]  reduces  the  death  rate  when 
compared  to  6  cycles  of  standard  therapy  [Arm  I]  in  this  subset  of  patients. 

Secondary  objectives:  Determine,  in  the  event  that  both  Arm  II  and  Arm  III  regimens  are  superior 
to  the  Arm  I  regimen  with  respect  to  overall  survival,  whether  the  Arm  III  regimen  reduces  the 
death  rate  when  compared  to  the  Arm  II  regimen;  determine  whether  the  Arm  II  or  Arm  III 
regimen  increases  the  duration  of  progression-free  survival  when  compared  with  the  Arm  I 
regimen;  compare  each  of  the  experimental  regimens  to  the  Arm  I  regimen  with  respect  to  the 
incidence  of  severe  side  effects  or  serious  adverse  events;  determine  the  impact  on  quality  of  life 
following  treatment  with  the  above  regimens;  assess  the  relationship  between  angiogenic  markers 
and  clinical  outcome  (tumor  response,  progression-free  survival,  overall  survival)  in  each  of  the 
Arms;  assess  the  predictive  value  of  a  set  of  genes  whose  expression  correlates  with  survival  in 
these  patients. 

Technical  Approach:  This  is  a  Phase  III  study  of  standard  chemotherapy  (carboplatin  plus 
paclitaxel)  versus  standard  plus  concurrent  bevacizumab  versus  standard  plus  extended 
bevacizumab  in  women  with  first  line,  advanced  stage  epithelial  ovarian  and  primary  peritoneal 
cancer.  Patients  with  a  histological  diagnosis  of  FIGO  Stage  III  or  IV  epithelial  or  peritoneal 
primary  cancer,  with  suboptimal  residual  disease  following  initial  surgery  will  be  screened  for 
enrollment.  Patients  who  qualify  will  be  enrolled  and  randomized  in  a  1:1:1  ratio  to  Arm  I,  II  or 
III.  Randomization  will  be  stratified  by  stage  of  disease  (Stages  III  versus  IV)  and  by  performance 
status  (0  versus  1  or  2).  All  patients  will  receive  standard  chemotherapy,  paclitaxel  175  mg/m2  IV 
over  3  hours  followed  by  carboplatin  AUC  6  IV  over  30  minutes  on  Day  1  of  a  21  day  cycle,  over  6 
cycles.  Dose  adjustments  will  be  made  per  protocol  for  changes  in  creatinine  clearance  and  for 
toxicities.  Patients  in  Arm  I  will  also  receive  placebo  on  Dayl  of  Cycle  2  through  6,  the  placebo 
every  21  days  for  an  additional  15  months.  Patients  on  Arm  II  will  receive  bevacizumab  on  Day  1 
of  Cycle  2  through  6,  and  placebo  every  21  days  for  an  additional  15  months.  Patients  on  Arm  III 
will  receive  bevacizumab  on  Day  1  of  Cycle  2  through  6,  and  bevacizumab  every  21  days  for  an 
additional  15  months.  Bevacizumab  will  be  given,  15  mg/mg,  IV,  per  package  insert.  During  initial 
chemotherapy,  patients  will  be  assessed  at  the  start  of  each  cycle  by  physical  exam,  laboratory 
tests  including  CBC,  chemistry,  LFTs,  and  CA-125.  Patients  on  anticoagulant  therapy  will  have  a 
repeat  PT,  PTT  and  INR  prior  to  each  cycle.  Blood  pressure  will  be  monitored  at  least  weekly 


187 


during  the  first  cycle,  then  prior  to  each  cycle  afterwards.  Radiographic  measurements  will  be 
repeated  prior  to  every  other  cycle.  During  bevacizumab/placebo  treatment  these  same 
assessments  will  be  done  every  other  cycle.  Post  treatment,  patients  will  be  followed  every  3 
months  for  2  years,  every  6  months  for  three  years,  then  annually. 

Progress:  This  greater  than  minimal  risk  protocol  received  initial  approval  with  stipulations 
during  the  convened  IRB  meeting  on  25  July  2006.  CIRO  approval  was  obtained  2  November  2006. 


188 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206054  Status:  Ongoing 

Title:  NSABP  B-38  A  Phase  III  Adjuvant  Trial  Comparing  Three  Chemotherapy  Regimens  in 

Women  with  Node-Positive  Breast  Cancer:  Docetaxel/Doxorubicin/Cyclophosphamide  (TAC); 

Dose-Dense  (DD)  Doxorubicin/Cyclophosphamide  Followed  by  DD  Paclitaxel  (DD  AC-P);  DD 

Doxorubicin/Cyclophosphamide  Followed  by  DD  Paclitaxel  Plus  Gemcitabine  (DD  AC-PG) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

4/12/2006  -  Feb  2011  CTSU  N/A 

Study  Objective:  The  primary  aims  of  this  study  are  to  determine  whether  the  DD  AC/PG 
regimen  is  superior  to  the  TAC  regimen  as  well  as  to  the  DD  AC/P  regimen  in  improving  disease- 
free  survival  and  to  compare  the  relative  disease-free  survival  of  TAC  and  DD  AC/P.  Secondary 
aims  are  to  determine  whether  DD  AC/PG  is  superior  to  TAC  as  well  as  to  DD  AC/P  in  improving 
overall  survival,  recurrence-free  interval,  and  distant  recurrence-free  interval;  to  compare  overall 
survival,  recurrence-free  interval,  and  distant  recurrence-free  interval  of  the  TAC  and  DD  AC/P 
regimens,  and  to  compare  the  relative  toxicities  of  the  three  regimens. 

Technical  Approach:  This  Phase  III  adjuvant  therapy  trial  for  women  with  node-positive  breast 
cancer  will  compare  three  regimens  of  chemotherapy:  (1)  TAC:  docetaxel,  doxorubicin,  and 
cyclophosphamide  every  3  weeks  for  6  cycles,  (2)  DD  AC/P:  doxorubicin/cyclophosphamide  every  2 
weeks  for  4  cycles  followed  by  paclitaxel  every  2  weeks  for  4  cycles  (3)  DD  AC/PG: 
doxorubicin/cyclophosphamide  every  2  weeks  for  4  cycles  followed  by  paclitaxel  plus  gemcitabine 
every  2  weeks  for  4  cycles.  Women  with  operable,  invasive  carcinoma  of  the  breast  with 
histologically  positive  axillary  nodes  will  be  enrolled  and  stratified  by  number  of  positive  nodes, 
hormone  receptor  status,  and  type  of  surgery  and  planned  radiotherapy.  Following  stratification, 
patients  will  be  randomized  to  one  of  the  three  chemotherapy  regimens.  Women  with  ER  positive 
and/or  PgR-positive  tumors  should  receive  hormonal  therapy  for  a  minimum  of  5  years  following 
completion  of  chemotherapy.  All  women  who  have  had  a  lumpectomy  will  have  radiation  therapy. 
Chest  wall  and  regional  nodal  irradiation  will  be  prospectively  determined  at  the  discretion  of  the 
investigator  and  will  be  used  as  a  stratification  factor.  For  patients  who  agree  to  specimen 
banking,  index  tumor  blocks  as  well  as  tumor  blocks  collected  after  diagnosis  of  contralateral 
breast  cancer  will  be  submitted.  Serum  will  be  collected  at  baseline,  at  the  time  of  first 
locoregional  or  distant  recurrence,  and  when  a  contralateral  breast  cancer  develops  prior  to 
locoregional  or  distant  recurrence.  If  the  first  recurrence  is  an  ipsilateral  breast  tumor  recurrence, 
a  serum  sample  will  also  be  collected  at  the  time  of  the  first  subsequent  regional  or  distant 
recurrence.  The  study  will  enroll  4800  patients  over  a  period  of  approximately  4  years.  It  is 
anticipated  that  the  definitive  analysis  will  be  carried  out  approximately  7  years  after  study 
initiation. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  one  patient  enrolled  during  FY06. 
Multiple  external  adverse  events  have  been  reported. 


189 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206073 

Status:  Ongoing 

Title:  Phase  1/2  study  of  ZK-Epothilone  (ZK-Epo;  ZK  219477)  in  combination  with  carboplatin  in 
patients  with  platinum-sensitive,  recurrent  ovarian  cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

7/11/2006  -  May  2010  Berlex  Laboratories  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Primary  objective:  to  establish  a  dose  of  ZK-Epo  to  be  used  in  combination  with 
carboplatin  in  the  subsequent  Part  2  of  the  study.  Secondary  objective:  to  investigate  the 
pharmacokinetics  of  ZK-Epo  and  carboplatin  when  given  as  a  combination.  Part  2:  Primary 
objective:  to  investigate  the  efficacy  of  ZK-Epo  in  combination  with  carboplatin  in  patients  with 
platinum-sensitive,  recurrent  ovarian  cancer  in  progression  following  a  first  regimen  of 
chemotherapy.  Secondary  objective:  to  investigate  the  safety  and  tolerability  of  ZK-Epo  in 
combination  with  carboplatin  in  this  patient  population. 

Technical  Approach:  This  is  a  Phase  I  /  II,  open  label  study  of  ZK-Epothilone  (ZK  219477)  in 
combination  with  carboplatin  in  patients  with  platinum  sensitive,  recurrent  ovarian  cancer. 
Patients  will  be  eligible  who  have  progressed  after  having  had  one  prior  chemotherapy  regimen 
including  a  platinum  compound,  and  who  have  had  a  response  lasting  between  6  and  24  months. 
Phase  I  of  the  study  will  enroll  up  to  18  patients  in  cohorts  of  6.  Patients  will  initially  be  treated  at 
12  mg/m2.  Depending  on  the  observed  Dose  Limiting  Toxicities  (DLT)  the  dose  will  either  be 
decreased  to  9  mg/m2  or  increased  to  15  mg/m2.  Patients  who  develop  a  DLT  will  be  withdrawn 
from  the  study.  Patients  in  Phase  I  will  be  required  to  participate  in  a  pharmacokinetic  study  to 
examine  the  metabolism  of  ZK-Epo  in  combination  with  carboplatin.  Patients  may  also  participate 
in  an  optional  pharmacogenetic  substudy.  Patients  who  participate  in  Part  I  who  appears  to 
benefit  from  treatment  can  continue  to  receive  additional  cycles  of  ZK-Epo  at  the  dose  level  at 
which  they  started  treatment.  Phase  II  of  the  study  will  use  the  treatment  dose  determined  in 
Phase  I.  Up  to  30  patients  will  be  enrolled,  for  a  total  of  32  evaluable  patients.  Patients  in  both 
phases  will  be  scheduled  to  receive  2  to  6  cycles  of  treatment.  ZK-Epo  will  be  given  per  dose 
escalation,  as  a  3-hour  IV  infusion,  on  Day  1  of  a  21  day  cycle.  Carboplatin  will  be  given  at  an  AUC 
of  5,  as  a  30  minute  infusion,  after  ZK-Epo.  Patients  will  sign  an  approved  consent  form  prior  to 
any  study-related  procedures.  Initial  evaluation  will  include  physical  exam  and  history,  review  in 
inclusion  criteria,  disease  assessment  by  CT,  MRI  or  CA-125  level,  EKG,  and  laboratory  tests 
including  CBC,  chemistry  and  LFT's.  PE  and  labs  will  be  repeated  for  each  cycles,  disease 
assessment  will  be  repeated  every  other  cycle.  Patients  will  continue  treatment  until  they  have 
received  6  cycles,  progress,  or  are  unable  to  tolerate  treatment.  After  treatment  patients  will  be 
followed  until  disease  progression.  Pharmacokinetic  studies  will  be  done  for  all  patients  on  Phase 
I,  and  is  option  for  patients  on  Phase  II.  This  will  consist  of  thirteen  2.7ml  samples  drawn  within 
the  first  12  hours,  and  one  sample  on  days  2,  3,  4,  5,  8  and  15.  PK  samples  will  only  be  drawn  for 
the  first  two  cycles  of  a  patient's  treatment.  Additional  pharmacogenetic  studies  are  optional  for 
all  patients,  and  consist  of  a  single  blood  sample  drawn  prior  to  initiation  of  therapy. 

Progress:  This  protocol  is  open  to  patient  entry,  but  patient  enrollment  has  not  been  initiated 
pending  the  outcome  of  discussions  with  the  study  sponsor  concerning  the  cost  language  in  the 
MAMC  informed  consent  document. 


190 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204008 

Status:  Ongoing 

Title:  Phase  II  Trial  of  ONTAK®  in  Refractory  or  Relapsed  Advanced  Non-small  Cell  Lung 

Cancer  (NSCLC) 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

1/8/2004  -  Nov  2005  Ligand  Pharmaceuticals,  Inc.  via  Henry  M. 

Jackson  Foundation 

Periodic  Review: 

10/19/2006 

Study  Objective:  (1)  To  evaluate  the  safety  of  ONTAK®  (denileukin  diftitox,  DAB389IL-2)  in 
patients  with  NSCLC,  (2)  To  evaluate  the  efficacy  of  ONTAK®  in  patients  with  NSCLC.  (3)  To 
evaluate  the  value  of  soluble  Interleuikin-2  receptors  (IL2R)  in  predicting  tumor  response  (or 
reaction)  to  ONTAK®.  (4)  To  evaluate  the  correlation  between  tumor  IL2R  status  and  disease 
response  to  treatment. 

Technical  Approach:  This  is  a  Phase  II  multicenter  non-randomized  open  label  clinical  trial.  Up 
to  50  subjects  will  be  enrolled  in  the  overall  study  with  a  goal  of  having  42  evaluable  subjects.  At 
MAMC,  2-4  subjects  may  be  enrolled  from  subjects  receiving  treatment  for  lung  cancer  in  the 
Hematology  and  Oncology  Clinic.  Treatment  will  consist  of  IV  administration  of  ONTAK®  daily  for 
5  days  every  3  weeks.  Safety  assessments  will  include  laboratory  hematology  and  blood  chemistry 
tests,  physical  exam  and  vital  signs,  and  ECOG  status  and  toxicity  assessments. 

During  the  first  cycle  of  treatment,  toxicities  will  be  evaluated  weekly  using  the  NCI  Common 
Toxicity  Criteria,  then  each  cycle  afterwards.  Serious  Adverse  Events  will  be  reported  to  the  IRB, 
FDA,  and  to  the  study  drug  manufacturer.  Tumor  response  will  be  assessed  by  physical  exam,  CT 
scan,  and  other  appropriate  imaging  studies  performed  every  2  cycles  and  evaluated  using  the 
RECIST  criteria.  Subjects  with  tumor  response  or  stable  disease  will  receive  up  to  6  cycles  of  study 
treatment.  Subjects  with  progressive  disease  or  unacceptable  toxicity  will  be  removed  from  the 
study.  Interim  evaluation  is  planned  after  the  first  14  evaluable  subjects.  If  no  subjects  experience 
an  objective  response  or  stable  disease,  then  the  study  will  be  terminated.  Soluble  IL2  receptor 
(IL2R)  levels  in  serum  will  be  measured  to  study  the  value  in  predicting  tumor  reaction  or 
response  to  the  treatment,  and  evaluation  of  tumor  IL2R  status  and  CD  25  staining  will  be 
performed  by  the  central  study  site  laboratory.  Primary  efficacy  endpoints  are  the  response  rate, 
overall  survival,  and  time  to  disease  progression.  Primary  safety  endpoints  are  the  number  of 
cycles  of  therapy  administered  and  the  type  and  grade  of  toxicities.  Secondary  endpoints  will  be 
the  level  of  soluble  IL-2  receptor  in  serum  and  receptor  expression  in  the  tumor  tissue  (positive  or 
negative). 

Progress:  This  protocol  closed  to  enrollment  with  two  subjects  enrolled.  One  subject  is  deceased 
and  the  other  subject  continued  to  be  followed  during  FY06. 


191 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206084  Status:  Ongoing 

Title:  Pilot  Study  to  Evaluate  the  Safety  and  Efficacy  of  PROCRIT  (Epoetin  alfa)  80,000  Units 
Once  Every  Four  Weeks  (Q4W)  vs.  40,000  Units  Once  Every  Two  Weeks  (Q2W)  in  Cancer 
Patients  with  Non-Chemotherapy  Anemia 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

7/12/2006  -  Dec  2009  Henry  M.  Jackson  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Objectives:  To  investigate  the  safety  and  efficacy  of  PROCRIT  80,000  units  (U) 
once  every  4  weeks  and  40,000U  once  every  2  weeks  subcutaneously  in  anemic  subjects  with 
cancer  not  receiving  chemotherapy  or  radiation  therapy  and  to  assess  the  effects  of  the  dosing 
regimens  on  time-to-  hematopoietic-response,  and  transfusion  requirements. 

Technical  Approach:  This  is  a  prospective,  randomized,  open-label,  multi-center  pilot  study  to 
evaluate  the  safety  and  efficacy  of  PROCRIT  (Epoetin  alfa)  80,000  Units  once  every  four  weeks 
versus  40,000  Units  (U)  once  every  two  weeks  in  cancer  patients  with  non-chemotherapy  anemia. 
A  total  of  100  subjects  will  be  enrolled  and  up  to  10  at  MAMC.  Patients  with  confirmed  non- 
myeloid  malignancy,  who  are  anemic,  and  not  receiving  chemotherapy  or  radiation  will  be 
randomized  in  to  one  of  two  treatment  groups  receiving  Procrit.  Safety  data  that  will  be  obtained 
during  the  study  includes  height,  weight,  blood  tests,  blood  pressure  and  incidence  and  severity  of 
adverse  events.  Patients  will  be  randomized  to  one  of  two  treatments  groups  receiving  PROCRIT 
subcutaneously.  The  starting  dose  will  be  either  80,000  U  every  4  weeks  with  a  maximum 
treatment  period  of  13  weeks  or  40,000  U  every  2  weeks  with  a  maximum  period  of  15  weeks.  A 
follow-up  visit  will  occur  for  both  treatment  groups  on  weeks  17.  Hemoglobin  levels  will  be 
obtained  every  week  to  monitor  hemoglobin  rate  of  rise  for  safety.  The  target  hemoglobin  is  10  to 
12  g/dL.  Patient  will  be  screened  for  study  eligibility  at  the  screening  visit  occurring  up  to  14  days 
prior  to  treatment  with  study  drug  unless  otherwise  specified.  They  will  be  followed  up  to  week  17. 
An  interim  analysis  will  be  performed  when  the  first  40  enrolled  subjects  have  completed  or 
withdrew  from  the  study.  The  primary  efficacy  end  point  will  be  hematopoietic  response,  defined 
as  <  1  g/dL  rise  in  hemoglobin. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  no  patients  enrolled. 


192 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204080 

Status:  Ongoing 

Title:  Protocol  U2963n:  The  National  Lymphocare  Study:  An  Observational  Study  of  Treatment, 
Outcomes,  and  Prognosis  in  Patients  With  Follicular  Non-Hodgkin's  Lymphoma 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

8/16/2004  -  Aug  2014  Genentech  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

5/22/2006 

Study  Objective:  The  objective  of  this  study  is  to  delineate  differences  in  treatment  outcome  for 
patients  with  follicular  non-Hodgkin's  lymphoma  (NHL)  by  comparing  the  outcomes  and  safety  of 
common  front-line  and  subsequent  therapeutic  strategies.  The  planned  comparisons  address 
clinical  questions  including  the  role  of  watchful  waiting,  use  of  anthracyclines  in  front-line 
therapy,  and  role  of  maintenance  therapy,  and  treatment  sequencing.  Reported  outcomes  for  a 
given  treatment  strategy  will  include  a  description  of  these  outcomes  based  on  Follicular 
Lymphoma  International  Prognostic  Index  (FLIPI)  score  risk  stratification  at  the  time  of  diagnosis 
and  subsequent  treatment  initiation. 

Technical  Approach:  This  is  a  prospective,  observational,  longitudinal,  multicenter  study  of 
patients  with  newly  diagnosed  follicular  Non-Hodgkin's  Lymphoma  (NHL).  12-18  patients  may  be 
enrolled  at  MAMC,  and  approximately  5000  patients  in  the  United  States.  A  database  will  be 
created  containing  patient  and  tumor  characteristics  and  treatment  and  outcome  information.  All 
patients  at  participating  sites  diagnosed  with  follicular  NHL  within  6  months  prior  to  enrollment 
will  be  eligible,  regardless  of  specific  treatments  received  (including  investigational  products)  and 
including  patients  followed  using  a  watch-and-wait  approach.  Patients  will  receive  treatment  and 
evaluations  for  NHL  according  to  the  treating  physician's  standard  of  care  and  clinical  practice.  No 
study- specific  visits,  interventions  or  patient  evaluations  will  be  conducted.  Patient  data  will  be 
collected  from  medical  records  and  reported  by  means  of  a  Web-based  Electronic  Data  Collection 
System  (EDC).  All  treatments  patients  receive  for  NHL  will  be  recorded  and  treatment  outcomes 
will  be  collected  quarterly.  Enrolled  patients  will  be  followed  for  up  to  10  years  or  until  death, 
withdrawal  of  consent,  loss  to  follow  up,  or  study  termination.  Study  feasibility  reviews  will  be 
conducted  at  2,  5,  7,  and  10  years.  Outcome  measures  include:  time  from  initial  diagnosis  to  initial 
therapy;  time  from  initial  therapy  to  subsequent  therapy,  response  to  treatment  (initial  and 
subsequent)  as  assessed  by  the  treating  physician;  time  to  disease  progression;  survival  time; 
lymphoma  treatment-related  toxicity  as  measured  by  death,  early  treatment  discontinuation,  and 
hospitalization;  and  FLIPI  score.  This  is  an  observational  cohort  study  and  is  not  designed  to 
evaluate  a  predefined  hypothesis.  However,  effectiveness  and  safety  outcomes  will  be  analyzed, 
confidence  intervals  for  differences  will  be  reported,  and  standard  statistical  tests  will  be 
performed,  with  the  first  evaluation  taking  place  after  approximately  500  patients  have  been 
enrolled  for  at  least  6  months. 

Progress:  This  protocol  remains  open  to  enrollment  with  four  subjects  consented.  One  subject  has 
died  and  three  continued  to  be  followed  at  MAMC  during  FY06. 


193 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202107  Status:  Completed 

Title:  Randomized  Study  of  Docetaxel  Versus  Docetaxel  Plus  GenasenseTM  (G3139;  Bcl-2 
Antisense  Oligonucleotide)  in  Patients  with  Previously  Treated  Non-Small  Cell  Lung  Cancer, 

No.  N304 

Principal  Investigator:  LTC  David  E.  McCune,  MC 


Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding: 

9/30/2002  -  Sep  2004  Genta  Inc  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

8/29/2006 

Study  Objective:  (1)  To  compare  the  survival  of  subjects  with  advanced  non-small  cell  lung 
cancer  treated  with  docetaxel  alone  versus  docetaxel  combined  with  Genasense  (Bcl-2  antisense 
oligonucleotide). (2)  To  compare  response,  time  to  progression,  tumor-related  symptoms,  and  safety 
in  the  two  treatment  groups. 

Technical  Approach:  In  this  advanced  non-small  cell  lung  cancer  study  antisense  treatment  will 
be  given  with  Taxotere  (docetaxel)  and  tumor  response  and  safety  will  be  compared  to  therapy 
with  Taxotere  alone.  This  study  is  a  randomized,  multicenter,  open  label,  Phase  III  design  clinical 
trial.  This  Phase  III  study  will  include  a  minimum  of  280  patients  randomized  in  a  1:1  ratio  to 
Docetaxel  or  Docetaxel  +  Genasense.  Approximately  35  centers  will  participate.  Study  endpoints 
include  the  primary  efficacy  variable  of  survival  and  secondary  efficacy  variables  of  response  rate, 
proportion  of  patents  surviving  at  6  and  12  months,  duration  of  response,  time  to  disease 
progression  and  other  measures  of  clinical  benefit  such  as  change  in  performance  status.  All 
patients  in  the  study  will  be  prospectively  stratified  by  response  to  prior  chemotherapy  regimen, 
ECOG  performance  status  and  prior  paclitaxel  treatment. 

Progress:  This  protocol  closed  to  enrollment  in  July  2004,  when  accrual  goals  were  met.  Three 
subjects  enrolled  at  MAMC;  all  were  reported  deceased  by  July  2005,  due  to  disease  progression.  A 
site  close  out  visit  was  reported  in  September  2006. 


194 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206055 

Status:  Ongoing 

Title:  SWOG  S0424:  Molecular  Epidemiology  Case-Series  Study  of  Non-Small  Cell  Lung  Cancer 
in  Smoking  and  Non-Smoking  Women  and  Men 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

8/3/2006  -  Feb  2011  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  To  assess  lung  tissue  from  cancer  patients  for  specific  tobacco  smoke 
carcinogens,  alterations  in  specific  genes,  and  to  determine  whether  these  factors  differ  by  gender 
and  smoking  status,  adjusting  for  potential  exposures  and  influential  factors  including  family 
smoking  status,  medication  use,  hormonal  and  reproductive  factors.  To  measure  levels  of  (PAH)- 
DNA  adducts  in  tissues  and  see  if  levels  are  higher  in  females  than  males  for  the  same  level  of 
smoking. 

Technical  Approach:  Eligible  patients  would  be  asked  to  complete  a  questionnaire  about 
smoking,  reproductive  history,  occupational  exposures  and  other  factors.  Samples  of  cancer  tissue 
obtained  at  the  time  of  biopsy  or  operation  would  be  sent  to  a  special  laboratory  to  study  genetic 
changes  that  may  explain  why  women  are  more  susceptible  to  tobacco  smoke  chemicals.  A  blood 
specimen  would  be  sent  to  a  special  laboratory  for  scientific  testing  to  help  learn  more  about  the 
causes  of  lung  cancer  and  who  is  at  risk  to  identify  who  would  benefit  from  intensive  screening  and 
possible  interventions.  The  results  of  the  testing  will  not  be  released  to  the  patient  or  study 
physician. 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled  during  FY06. 


195 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206013 

Status:  Ongoing 

Title:  SWOG  S0435  A  Phase  II  Trial  of  BAY  43-9006  (SNC-724772)  in  Patients  with  Platinum- 
Treated  Extensive  Stage  Small  Cell  Lung  Cancer 

Principal  Investigator:  LTC  David  E.  McCune,  MC 

Department:  Medicine/Hematology  &  Oncology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  MAJ  Angela  G.  Mysliwiec,  MC 

Start  -  Completion:  Funding: 

1/18/2006  -  Nov  2010  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

11/21/2006 

Study  Objective:  Primary  endpoints:  to  evaluate  the  efficacy  of  BAY  43-9006  in  previously- 
treated,  platinum-sensitive  and  platinum-refractory  patients  with  measurable  disease  and 
extensive  stage  small  cell  lung  cancer  (E-SCLC)  in  terms  of  response  rate  (confirmed  and 
unconfirmed,  complete  and  partial).  Secondary  endpoints:  to  assess  the  qualitative  and 
quantitative  toxicities  of  BAY  43-9006  in  this  patient  population.  To  assess  overall  survival  in  this 
group  of  patients  treated  with  BAY  43-9006.  To  collect  specimens  via  the  Lung  Cancer  Specimen 
Repository  Protocol  (S9925)  in  order  to  perform  exploratory  analyses  of  the  relationship  between 
selected  markers  and  patient  outcomes. 

Technical  Approach:  This  is  a  Phase  II,  multi-center  trial  of  BAY  43-9006  in  patients  with 
platinum-treated  extensive  stage  small  cell  lung  cancer.  BAY-43-9006,  or  Sorafenib,  is  a  compound 
that  inhibits  multiple  tyrosine  kinase  pathways  involved  in  tumor  progression.  Patients  will  be 
enrolled  who  have  had  prior  treatment  with  platinum  based  therapy.  Accrual  will  proceed 
separately  in  two  strata  based  on  whether  patients  are  platinum  sensitive  or  resistant.  Patients 
will  undergo  screening,  with  medical  history  and  physical,  head  and  chest  CT  scans,  bone  scan  if 
indicated,  and  blood  tests  for  chemistry  and  CBC.  Patients  will  also  be  offered  participation  in 
S9925,  a  companion  study  for  specimen  submission.  Eligible  patients  will  be  treated  with  an  oral 
dose  of  BAY  43-9006,  400mg  twice  a  day  in  a  4  week  cycle  until  disease  progression.  Ongoing 
assessments  will  include  weekly  toxicity  assessment,  CBC  every  other  week,  and  physical  exam 
chemistry  every  4  weeks.  Disease  assessment  will  include  scans  every  8  weeks  during  treatment, 
and  every  3  months  after  treatment  for  up  to  2  years  after  enrollment,  or  until  death.  Enrollment 
will  continue  until  20  each  of  platinum  sensitive  and  platinum  resistant  patients  have  been 
enrolled,  after  which  an  additional  20  patients  will  be  enrolled  to  each  group  if  there  has  been  at 
least  one  response  to  treatment. 

Progress:  This  protocol  remains  open  to  patient  entry  to  the  platinum  refractory  arm  of  the  study. 
One  patient  enrolled  during  FY06,  but  died  of  progressive  disease  after  declining  further 
treatment  due  to  serious  adverse  events  of  gait  instability,  slurred  speech  and  confusion. 


196 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205036  Status:  Ongoing 

Title:  CTSU  NSABP  C-08,  A  Phase  III  Clinical  Trial  Comparing  Infusional  5-Fluorouracil  (5- 
FU),  Leucovorin,  And  Oxaliplatin  (mFOLFOX6)  Every  Two  Weeks  With  Bevacizumab  To  The 
Same  Regimen  Without  Bevacizumab  For  The  Treatment  Of  Patients  With  Resected  Stages  II 
And  III  Carcinoma  of  the  Colon 

Principal  Investigator:  MAJ  Angela  G.  Mysliwiec,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  LTC  David  E.  McCune,  MC;  MAJ  Jasmine  T.  Daniels,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/3/2005  -  Mar  2009  SWOG  via  Henry  M.  Jackson  Foundation  1/24/2006 

Study  Objective:  Primary  Objective  is  to  compare  the  relative  efficacy  of  mFOLFOX6  + 
bevacizumab  with  that  of  mFOLFOX6  alone  in  prolonging  disease-free  survival  (DFS).  Secondary 
Objective  is  to  compare  the  relative  efficacy  of  mFOLFOX6  +  bevacizumab  with  that  of 
mFOLFOX6  alone  in  prolonging  survival  (S). 

Technical  Approach:  Eligible  subjects  will  be  randomized  into  one  of  the  two  study  groups. 
Patients  in  Group  1  will  receive  the  drugs  5-FU,  Leucovorin,  and  Oxaliplatin,  repeated  every  14 
days  (one  cycle)  for  a  total  of  12  cycles  of  chemotherapy.  Patients  in  Group  2  will  receive  5-FU, 
Leucovorin,  and  Oxaliplatin,  repeated  every  14  days  (one  cycle)  for  a  total  of  12  cycles  of 
chemotherapy  and  also  receive  bevacizumab  on  day  1  of  each  cycle  before  receiving  the 
chemotherapy.  After  chemotherapy  is  done,  subjects  will  continue  to  receive  bevacizumab  once 
every  2  weeks  for  another  6  months.  Subjects  will  continue  to  be  followed  for  the  first  5  years  with 
physical  exams,  urine  and  blood  tests,  and  an  enema  with  x-ray  or  endoscopic  exam.  National 
accrual  is  expected  to  be  2632  patients  over  4  years.  Investigators  estimate  approximately  4 
patients  per  year  for  a  total  of  16  patients  enrolled  at  MAMC. 

Progress:  This  study  closed  to  enrollment  6  October  2006  after  NSABP  enrollment  goals  were 
met.  Four  patients  enrolled  at  MAMC  and  remained  in  treatment  or  follow-up  during  FY06. 


197 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206025  Status:  Terminated 

Title:  RegistHER:  An  Observational  Cohort  Study  of  Patients  with  HER2-Positive  Metastatic 
Breast  Cancer 

Principal  Investigator:  MAJ  Angela  G.  Mysliwiec,  MC 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  LTC  David  E.  McCune,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/14/2005  -  Jan  2011  DCI  N/A 

Study  Objective:  Objectives  are  to  describe  the  time  to  treatment  failure,  time  to  disease 
progression,  overall  survival,  incidence  of  clinically  significant  cardiac-related  adverse  events  in  a 
cohort  of  patients  with  HER2-positive  metastatic  breast  cancer  and  to  describe  and  compare  the 
outcomes  associated  with  common  therapies. 

Technical  Approach:  This  is  a  prospective  observational  cohort  study  designed  to  describe  the 
effectiveness  and  safety  (treatment  outcomes  and  clinically  significant  cardiac  adverse  events)  in 
patients  with  HER2-positive  metastatic  breast  cancer.  Enrolled  patients  will  receive  treatment 
and  evaluations  for  HER2-positive  metastatic  breast  cancer  as  determined  by  their  treating 
physicians  according  to  the  standard  of  care  and  clinical  judgement.  The  study  will  enroll  >  1000 
patients  over  approximately  2-3  years.  Patients  will  be  followed  from  enrollment  until  death, 
withdrawal  of  consent,  or  loss  to  follow-up. 

Progress:  This  protocol  was  terminated  2  March  2006,  due  to  failed  contract  negotiations  with  the 
study  sponsor.  The  study  was  never  initiated  at  MAMC. 


198 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204082  Status:  Ongoing 

Title:  Evaluating  Cognitive  Function  in  Women  Receiving  Chemotherapy  for  Newly  Diagnosed 

Breast  Cancer 

Principal  Investigator:  Margaret  J.  Ramsdell,  RN,  BSN,  OCN 

Department:  Medicine/Hematology  &  Oncology  Facility:  MAMC 

Associate  Investigator(s):  Donna  L.  Berry,  Ph.D.,  RN 

Start  -  Completion:  Funding:  Periodic  Review: 

5/25/2004  -  Oct  2004  DCI  5/22/2006 

Study  Objective:  To  evaluate  cognitive  function  in  women  newly  diagnosed  with  breast  cancer, 
receiving  chemotherapy  and  the  effect  of  cognitive  function  on  the  individual's  quality  of  life.  This 
study  will  examine  both  the  relationship  between  cognitive  function  scores  and  patient's  self- 
reported  cognitive  problems  and  the  meaning  of  the  measures  for  women  receiving  chemotherapy 
for  breast  cancer.  Specifically:  (1)  to  describe  function  scores  of  the  EORTC  QLQ  C-30  cognitive 
subscale  and  the  High  Sensitivity  Cognitive  Screen  (HSCS)  in  women  with  breast  cancer  at 
baseline  and  mid  point  in  chemotherapy  treatment  for  breast  cancer,  and  (2)  to  evaluate  the 
process  and  meaning  of  answers  on  the  HSCS  and  the  cognitive  subscale  questions  of  the  EORTC 
QLQ  C-30  questionnaire. 

Technical  Approach:  This  study  will  utilize  a  longitudinal,  pre-post  test  design  to  evaluate 
women  newly  diagnosed  with  breast  cancer  who  will  be  receiving  doxorubicin  and 
cyclophosphamide.  Women  ages  25-70,  newly  diagnosed  with  breast  cancer  will  be  asked  to 
participate  in  this  study.  Subjects  interested  will  fill  out  a  3x5  card  with  name  and  phone  number 
and  will  be  contacted  by  the  PI.  After  signing  consent  and  answering  questions,  patients  will  fill 
out  the  EORTC  QLQ  C-30  questionnaire.  Upon  completion  of  the  EORTC  QLQ  C-30  a  cognitive 
interview  of  those  questions  will  be  conducted  to  find  out  how  the  subjects  felt  about  reading  and 
answering  the  questions,  what  those  quesitons  mean  to  them  and  how  their  cognitive  function 
currently  is  affecting  their  quality  of  life.  The  HSCCS,  a  sensitive  tool  for  detecting  subtle 
cognitive  impairment,  will  be  administered  at  the  completion  of  the  cognitive  interview. 

Descriptive  statistics  will  be  used  to  summerize  the  demographic  characteristics  of  the  EORTC 
QLQ  C-30  cognitive  scale  scores  and  the  cognitive  domain  scores  on  the  HSCS  of  the  subjects  of 
two  time  points  per  chemotherapy  and  at  mid  point  during  chemotherapy.  The  Mann- Whitney  test 
will  be  used  to  compare  cognitive  scale  scores  on  the  EORTC  QLQ  C-30  and  cognitive  domain 
scores  on  the  HSCS  in  subjects  at  the  same  time  point.  The  results  at  both  time  points  will  be 
graded  and  examined  for  changes  in  scores  on  the  HSCS  as  well  as  changes  in  the  five  item 
subscale  of  the  EORTC  QLQ  C-30  . 

Progress:  This  protocol  closed  to  enrollment  in  May  2006,  with  6  subjects  enrolled.  Data  collection 
is  complete  and  the  study  remains  ongoing  to  complete  data  analysis  and  the  final  manuscript. 


199 


Detail  Summary  Sheets 

Internal  Medicine  Service,  Department  of 

Medicine 


200 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205046 

Status:  Ongoing 

Title:  The  Effect  of  Blood  Transfusion  on  Serum  Ferritin  and  Iron 

Principal  Investigator:  CPT  Corinna  Avalos,  MC 

Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Ashley  A.  Feaver,  MC;  LTC  Rajat  Bannerji,  MC;  CPT  Daniel 

G.  Cuadrado,  MC;  COL  Ronald  H.  Cooper,  MC;  CPT  Patrick  M.  McNutt,  MS 

Start  -  Completion:  Funding: 

5/26/2005  -  Mar  2006  DCI 

Periodic  Review: 

1/24/2006 

Study  Objective:  To  study  the  effect  of  packed  red  blood  cell  transfusion  on  ferritin  level  and  iron 
panel. 


Technical  Approach:  In  this  descriptive  study  a  database  containing  demographic  and  medical 
information  will  be  constructed  for  patients  who  have  anemia  requiring  non-emergent  packed  red 
blood  cell  transfusions.  Candidates  for  the  study  will  be  identified  by  a  list  of  excluding  medical 
conditions  a  physician  will  go  through  prior  to  the  transfusion  and  consent.  Eligible  patients  who 
consent  to  the  study  will  have  their  iron  panel  and  ferritin  levels  drawn  prior  to  transfusion  and 
six  other  times  as  specified  after  transfusion. 

Progress:  This  protocol  remains  ongoing  at  MAMC,  with  four  out  of  five  subjects  completing  the 
required  lab  work.  One  subject  died  prior  to  completing  the  lab  work;  this  death  was  unrelated  to 
study  participation.  Due  to  time  constraints,  enrollment  has  been  on  hold,  but  investigators  plan 
to  resume  enrollment  during  FY07. 


201 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205123  Status:  Ongoing 

Title:  Current  Use  and  Complications  of  Peripherally  Inserted  Central  Catheters  (PICC):  A 
Retrospective  Study 

Principal  Investigator:  CPT  Kathleen  C.  Bauler,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Joel  T.  Abbott,  MC;  MAJ  Alexander  S.  Niven,  MC;  MAJ  Cecily 
K.  Peterson,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/18/2005  -  Jun  2006  DCI  9/21/2006 

Study  Objective:  Evaluate  the  indications  for  placement,  duration  of  therapy  and  complications 
of  peripherally  inserted  central  catheters  (PICC)  lines  in  the  inpatient  population  at  Madigan 
Army  Medical  Center. 

Technical  Approach:  This  is  a  retrospective  chart  review  of  consecutive  inpatients  with  PICC 
lines  as  identified  from  PICC  service  records.  Subjects  without  documentation  of  a  minimum  of  one 
endpoint  will  be  excluded  from  further  analysis  and  recorded  by  clinical  service  as  "no  data 
available."  A  data  sheet  will  be  completed  for  subjects  with  a  minimum  of  one  recorded  end  point 
(PICC  line  placement,  removal  or  "unknown"  re:  PICC).  Each  subject's  demographics,  pertinent 
medical  history,  indication,  duration,  and  complications  of  PICC  line  placement,  nurse  placing 
PICC  line  and  years  of  experience  will  be  recorded.  100  consecutive  subject's  charts  will  be 
reviewed  using  this  criterion.  Primary  variables  will  be  indication,  duration  of  therapy,  and 
complications.  Subjects  with  and  without  complications  will  be  separated  and  analyzed  by 
indication,  duration  of  therapy,  demographic  and  medical  information,  and  nursing  information. 
Data  will  be  analyzed  using  Chi-squared,  ANOVA  and  MANOVA  analysis. 

Progress:  This  retrospective  review  protocol  continues  to  collect  patient  information.  Several 
patient  charts  selected  were  found  not  to  have  had  PICC  lines  placed;  rather  patients  had  other 
central  lines  placed.  The  PI  has  discussed  other  means  of  collecting  data  on  patients  with  PICC 
lines.  At  this  time,  25  patients  out  of  nearly  70  reviewed  have  been  eligible  for  analysis. 


202 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205039 

Status:  Ongoing 

Title:  Management  of  Parapneumonic  Effusions:  Does  Following  Pneumonia  Treatment 
Guidelines  Affect  Outcome?  A  Retrospective  Study 

Principal  Investigator:  CPT  Patricia  J.  Dehaan,  MC 

Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  COL  Bernard  J.  Roth,  MC;  John  G.  Meyer,  MD 
Rinard,  MC 

;  MAJ  John  P. 

Start  -  Completion:  Funding: 

2/11/2005 -Aug  2005  DCI 

Periodic  Review: 

1/12/2006 

Study  Objective:  To  determine  whether  pneumonia  treatment  guidelines  are  being  followed  at 
Madigan  Army  Medical  Center  in  managing  parapneumonic  effusion  and  whether  outcome  is 
affected  via  retrospective  chart  review. 


Technical  Approach:  This  is  a  retrospective  study  of  parapneumonic  effusions  in  patients  with 
the  diagnosis  of  community-acquired  pneumonia  (CAP).  Adult  patients  (age  18  years  and  older) 
that  meet  the  diagnosis  of  pneumonia  will  be  studied  to  determine  whether  a  parapneumonic 
effusion  (PPE)  was  present  at  time  of  diagnosis  and  if  pneumonia  management  guidelines 
published  by  the  IDSA  and  ATS  were  followed.  If  a  PPE  was  present  on  chest  radiograph,  was  a 
lateral  decubitus  study  or  CT  scan  then  done?  If  the  PPE  layered  >10  mm  on  lateral  decubitus 
radiograph,  was  thoracentesis  done?  Did  it  change  patient  management  and  was  outcome  affected? 
If  no  difference  of  outcome  is  found,  should  the  pneumonia  management  guidelines  be  updated? 
This  study  will  look  at  patients  given  the  diagnosis  of  CAP  during  the  time  frame  from  01  Jan  02 
to  31  Dec  03. 

Progress:  This  protocol  remains  ongoing.  Data  collection  is  complete  but  investigators  are 
compiling  the  findings  for  publication  in  a  medical  journal. 


203 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206119  Status:  Ongoing 

Title:  Urinary  Markers  of  Renal  Injury  and  N- Acetylcysteine  Efficacy  (URINE) 

Principal  Investigator:  CPT  Nathan  R.  Evans,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  COL  Howard  M.  Cushner,  MC;  MAJ  Jason  L.  Davis,  MC;  CPT 
Mehdi  C.  Shelhamer,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

10/18/2006  -  Mar  2007  DCI  N/A 

Study  Objective:  The  objective  of  this  study  is  to  attempt  to  measure  NAC's  effect  at  the  renal 
tubular  cell  level  by  measuring  two  known  markers  for  renal  cell  injury  after  a  contrast  load.  A 
secondary  objective  will  be  to  look  into  differences  in  these  urinary  enzyme  levels  based  on  how 
much  IV  contrast  volume  was  given  in  both  the  study  and  control  groups. 

Technical  Approach:  Up  to  90  patients  who  have  been  scheduled  for  a  radiologic  imaging  study 
with  IV  contrast  or  heart  catheterization  will  be  recruited  for  this  study.  An  additional  45  patients 
scheduled  for  a  non-invasive  imaging  study  such  as  an  ultrasound  will  also  be  recruited.  The  goal 
is  to  enroll  135  patients  who  complete  the  study.  Patients  will  be  stratified  by  age  (<50  and  >50) 
and  creatinine  clearance  (60-90  versus  >90)  as  calculated  by  the  MDRD  equation20  using  a 
completed  chem  7  or  14.  The  patients  undergoing  a  heart  catheterization  or  IV  radiologic  imaging 
study  will  be  randomized  to  either  NAC  or  no  NAC  using  a  computer  program  based  on  random 
number  generation.  NAC  will  be  administered  in  4  ounces  of  orange  juice  and  control  patients  will 
receive  an  equivalent  volume  of  normal  saline  (as  NAC),  also  in  4  ounces  of  orange  juice.  Patients 
will  be  blinded  to  treatment  and  questioned  as  to  which  treatment  they  believe  they  received  after 
the  first  dose  and  at  the  end  of  the  study.  45  patients  will  be  enrolled  in  a  study  group  receiving 
NAC  prophylaxis  for  their  contrast  study.  45  patients  will  serve  in  a  control  group,  which  will  not 
receive  NAC.  The  study  will  remain  open  until  45  patients  are  enrolled  in  each  group.  GGT  and 
NAG  will  be  measured  from  urine  collections  prior  to  the  administration  of  NAC  and  contrast  and 
24  hours  after  the  administration  of  contrast.  A  50  cc  spot  urine  specimen  will  be  collected  on  all 
patients  prior  to  taking  the  first  dose  of  NAC.  A  second  50  cc  spot  urine  specimen  will  then  be 
collected  24  hours  after  the  contrast  study.  Both  urine  specimens  will  be  used  to  measure  urine 
GGT  and  NAG  levels  standardized  per  gram  of  urine  creatinine.  The  age,  race,  sex,  baseline 
MDRD  GFR,  presence  of  diabetes,  use  of  ACE  inhibitor  and  amount  of  IV  contrast  volume  given  to 
each  patient  will  also  be  recorded.  Only  the  IND  pharmacist  will  be  aware  of  whether  NAC  is 
given  to  the  patient  (via  computer  generated  randomization).  Patients  and  investigators  will  be 
blinded  as  to  who  will  receive  NAC. 

Progress:  This  greater  than  minimal  risk  protocol  received  initial  approval  with  stipulations 
during  the  convened  IRB  meeting  on  22  August  2006.  Final  approval  was  granted  18  October 
2006. 


204 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206064 

Status:  Completed 

Title:  Does  Participation  in  a  Subspecialty  Elective  Rotation  Improve  the  Respective  American 
Board  of  Internal  Medicine  Subspecialty  Score? 

Principal  Investigator:  CPT  Collin  J.  Fischer,  MC 

Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Cecily  K.  Peterson,  MC; 

CPT  James  A.  Watts,  MC 

Start  -  Completion:  Funding: 

3/6/2006  -  May  2006  DCI 

Periodic  Review: 

N/A 

Study  Objective:  (1)  To  determine  if  internal  medicine  resident  participation  in  a  one  month 
internal  medicine  subspecialty  elective  significantly  affects  the  score  of  that  particular 
subspecialty  on  the  American  Board  of  Internal  Medicine  (ABIM)  Certification  Examination.  (2) 

To  determine  if  internal  medicine  resident  participation  in  all  eight  core  internal  medicine 
subspecialty  elective  rotations  (i.e.  cardiology,  pulmonary  medicine,  gastroenterology,  nephrology, 
infectious  disease,  rheumatology,  hematology/oncology  and  endocrinology)  confers  a  benefit  as 
measured  by  the  overall  ABIM  Certification  Examination  score  when  compared  to  residents  who 
did  not  participate  in  all  eight  core  internal  medicine  sub  specialty  elective  rotations  during 
residency  training.  (3)  To  determine  if  internal  medicine  resident  participation  in  four  months  or 
more  of  "non  medicine"  electives  during  residency  training  is  prognostic  of  a  significantly  worse 
overall  score  on  the  ABIM. 

Technical  Approach:  The  specific  subspecialty  clinical  rotations,  ABIM  Certifying  Examination 
(ABIMCE)  total  and  subspecialty  scores/deciles,  and  PGY-2  In  Training  Examination  (ITE)  total 
score  will  be  collected  for  each  subject.  Information  on  which  subspecialty  clinical  rotations  were 
completed  will  be  obtained  from  an  examination  of  clinical  evaluation  forms  completed  at  the  end 
of  each  clinical  rotation.  (1)  Participants  will  be  grouped  within  each  subspecialty  according  to 
number  of  months  they  spent  performing  that  subspecialty  elective  during  their  PGY  2  and  3  years 
(0,  1  and  >1  months).  Subjects  will  be  paired  according  to  their  PGY-2  ITE  percentile  by  year 
score.  ABIM  subspecialty  scores  will  be  compared  for  statistically  significant  differences  between 
groups  with  the  ANOVA  test.  (2)  Subjects  will  be  divided  into  2  groups  based  on  completion  of  the 
entire  set  of  8  internal  medicine  "core  electives"  (defined  above)  versus  non-completion.  Subjects 
will  then  be  paired  according  to  PGY-2  ITE  percentile  by  year  score.  Total  ABIMCE  scores  will  be 
compared  for  statistically  significant  differences  between  groups  with  a  2  tailed  Student's  t-test. 

(3)  The  number  of  "non-medicine"  electives  will  be  tallied  for  each  subject.  A  "non-medicine" 
elective  will  be  defined  as  any  elective  on  which  the  preponderance  of  time  is  spent  on  a  subject  not 
tested  on  the  ABIMCE.  Subjects  will  then  be  split  into  groups  based  on  participation  in  <4  or  >4 
"non-medicine"  elective  months  during  residency,  and  paired  according  to  their  PGY-2  ITE 
percentile  score.  Total  ABIMCE  scores  will  be  compared  for  statistically  significant  differences 
between  groups  with  a  2  tailed  Student's  t-test. 

Progress:  This  protocol  was  reported  completed  in  July  2006.  Results:  Mean  In- Training 
Examination  scores  during  the  PGY-2  year  was  64th  percentile.  The  average  ABIMCE  overall 
decile  for  the  group  was  7.2.  The  group  had  a  97%  first  time  pass  rate  on  the  ABIMCE.  Overall, 
performing  one  or  more  months  on  a  medicine  subspecialty  elective  did  not  correlate  with  higher 
sub-score  for  that  speciality.  In  addition,  completing  the  'core'  8  medicine  subspecialty  elective 
rotations  during  residency  did  not  predict  a  significantly  better  overall  score  on  the  ABIMCE. 
However,  performing  more  non-medicine  related  electives  was  correlated  with  a  significantly 
worse  overall  score  on  the  ABIMCE.  The  cut-off  for  this  significance  is  4  or  more  non-medicine 
rounds. 


205 


Conclusions:  Obtaining  ABIM  certification  is  an  expected  goal  of  Internal  Medicine  graduates  and 
residency  programs.  However,  the  ABIMCE  is  only  validated  to  assess  the  medical  knowledge 
competency.  Furthermore,  for  any  individual,  subspecialty  sub-scores  on  the  ABIMCE  are  only 
important  when  one  does  not  achieve  certification  on  the  first  attempt.  Hence,  the  factors  that 
drive  subspecialty  elective  choice  by  residents  (or  requirements  by  programs)  must  include  other 
issues  including  demonstrating  all  the  core  competencies  in  that  subspecialty  discipline. 

What  our  data  does  support  is  that  even  in  this  population  skewed  toward  above  average  success 
on  the  ABIMCE,  increased  numbers  of  non-medicine  electives  correlated  with  poorer  overall 
performance.  At  a  micro  level,  this  finding  may  influence  program  limitation  on  non-medicine 
electives  in  residents  at  risk  for  not  passing  the  ABIMCE  on  the  first  attempt.  At  a  macro  level, 
this  data  is  important  to  the  academic  Internal  Medicine  community  as  restructuring  residency 
training  is  being  considered  nationally. 


206 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205104 

Status:  Completed 

Title:  Appropriate  Use  of  CTPA  in  the  Evaluation  of  Pulmonary  Embolism 
Hospital-Wide  Referral  Practices 

-  An  Examination  of 

Principal  Investigator:  CPT  Cristin  A.  Kiley,  MC 

Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Vincent  Mysliwiec,  MC;  MAJ  Kristie  J.  Lowry,  MC 

Start  -  Completion:  Funding: 

7/12/2005  -  Jul  2006  DCI 

Periodic  Review: 

N/A 

Study  Objective:  The  primary  objective  of  this  study  is  to  ascertain  the  physician  ordering 
practices  for  CT  Pulmonary  Angiography  (CTPA)  in  the  context  of  diagnosing  pulmonary  embolism 
(PE)  and  to  determine  if  these  ordering  practices  meet  accepted  community  standards. 


Technical  Approach:  Patients  who  fit  the  initial  study  population  will  have  their  charts 
reviewed  by  the  investigators  who  will  determine  their  modified  Well's  score  for  probability  of 
pulmonary  embolism:  i.e.,  the  presence  of  a  d- Dimer  assay  will  be  noted  along  with  its  result,  EKG 
and  CXR  findings,  symptoms  upon  presentation,  the  result  of  the  CTPA  and  documentation  pre¬ 
test  and  post-test  will  all  be  reviewed.  Based  on  accepted  guidelines,  a  determination  will  be  made 
if  the  study  was  ordered  appropriately.  The  percentage  of  CTPAs  with  positive  findings  will  be 
calculated  and  correlated  with  the  number  of  studies  to  determine  if  MAMC  ordering  practices 
meet  community  standards.  Both  pre  and  post  test  documentation  concerning  follow-up  for 
incidental  abnormalities  found  on  CTPA  will  be  examined.  If  the  data  gathered  suggest  that 
MAMC  providers  are  ordering  CTPAs  inappropriately  compared  with  community  standards,  a 
proposal  for  initiating  referral  guidelines  for  CTPA  to  rule  out  PE  in  the  MAMC  health  care 
system  will  be  put  forth. 

Progress:  This  protocol  was  reported  completed  in  June  2006.  Results:  Of  394  charts  reviewed, 

303  patients  underwent  CTPA  imaging  and  were  included  in  further  analysis.  A  Simplified  Wells 
score  was  calculated  in  279  (92%)  subjects,  with  a  mean  score  of  1.6  +  1.6.  145  subjects  had  D- 
dimers  performed,  of  which  128  (88%)  were  positive.  20  CTPA  were  positive  for  VTE,  a  positive 
rate  of  7.2%.  No  subjects  had  a  negative  D-dimer  and  a  positive  CTPA.  Follow-up  imaging  was 
recommended  in  145  (52%)  of  cases.  Conclusion:  This  study  demonstrated  a  statistically  significant 
lower  rate  of  CTPA  positivity.  The  expected  positive  rate  for  MAMC  was  16%,  the  actual  rate  was 
7.2%  (p=.0004).  Additionally,  the  sensitivity  of  the  D-dimer  was  100%  with  a  specificity  of  22%. 

This  is  a  result  of  failure  to  adhere  to  a  validated  clinical  algorithm  to  assess  for  VTE  and  a  large 
proportion  of  low  clinical  probability  patients. 


207 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206087  Status:  Ongoing 

Title:  Hemoptysis  in  Young  Adults 

Principal  Investigator:  CPT  Herbert  P.  Kwon,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Vincent  Mysliwiec,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/8/2006  -  Aug  2006  DCI  N/A 

Study  Objective:  To  report  in  case  series  format  the  causes  of  hemoptysis  in  young  adults  as 
determined  by  bronchoscopy  at  the  MAMC  Pulmonary  clinic  in  a  retrospective  medical  record 
review. 

Technical  Approach:  A  retrospective  chart  review  will  be  performed  utilizing  the  MAMC 
Pulmonary  Clinic  Bronchoscopy  logbook  as  the  initial  source  of  patient  identification.  The  logbook 
for  the  years  of  2000-2006  will  be  screened  for  individuals  undergoing  bronchoscopy  within  the  age 
range  of  18  through  45  years  of  age.  The  indication  for  bronchoscopy  will  be  screened  for 
hemoptysis. 

Progress:  Nineteen  subject's  records  were  identified  for  inclusion  in  this  retrospective  review 
protocol  during  FY06.  The  results  collected  so  far  will  be  presented  at  Army  ACP,  November  2006 
in  Washington  D.C.  The  protocol  remains  ongoing  at  MAMC. 


208 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206069  Status:  Ongoing 

Title:  The  Effects  of  Nighttime  Low  Dose  Aspirin  on  Ambulatory  Blood  Pressure  Testing  in 

Treated  Hypertensive  Patients 

Principal  Investigator:  CPT  Herbert  P.  Kwon,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jason  L.  Davis,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/12/2006  -  Dec  2006  DCI  via  Spacelabs  N/A 

Study  Objective:  To  determine  the  benefits  of  aspirin  chronotherapy  in  patients  already  on  anti¬ 
hypertensive  therapy. 

Technical  Approach:  Eligible  patients  who  consent  to  participate  will  have  a  baseline  physical 
exam  performed  that  will  include  a  cardiovascular  exam.  If  signify  underlying  occult  organic  heart 
disease  is  detected  the  patient  will  not  be  included  in  the  study.  If  the  work  up  is  negative,  the 
patient  will  be  included  in  the  study.  After  an  evening  of  fasting,  patients  will  have  six  blood 
pressure  measurements  taken  after  sitting  for  at  least  5  minutes.  All  efforts  will  be  made  to 
ensure  the  measurements  are  taken  on  the  same  type  of  machine  by  the  same  individual,  and  at 
the  relatively  same  times  in  the  morning  (between  0800  and  1100).  Patients  will  be  randomly 
assigned  to  either  remain  on  their  aspirin  in  the  morning  or  to  take  it  nightly.  Patients  will  then 
have  physical  measurements  taken  and  their  fasting  blood  drawn.  Finally,  a  Spacelabs  90207 
Ambulatory  Blood  Pressure  Monitor  {ABPMj  (Issaquah,  Washington)  will  be  placed  and 
instructions  for  use  given. 

Ambulatory  Blood  Pressure  Monitor:  Patients  will  have  blood  pressure  and  heart  rates  measured 
every  20  minutes  between  0700  and  2300  if  they  are  civilian  and  0600  and  2200  if  they  military 
participants.  During  the  eight  hour  "rest  period"  patients  will  have  measurements  taken  every  30 
minutes.  Data  will  not  be  used  if  there  is  >30%  of  measurements  missing,  data  missing  for  more 
than  2  hours,  or  if  patients  fail  to  return  for  a  second  ambulatory  blood  pressure  measurement. 
After  returning  the  blood  pressure  monitor,  patients  will  receive  a  new  bottle  of  aspirin  with  a 
sticker  stating  if  the  medication  should  be  taken  in  the  morning  or  evening  in  addition  to  the 
normal  written  instructions,  which  will  conclude  initial  randomization  to  a  study  arm. 
Investigators  will  be  blinded  to  the  timing  of  aspirin  administration.  Measurements  will  be 
submitted  via  email  at  Months  0-3  (First  Inter-measurement  Period),  Month  3  (Interim 
Evaluation)  and  Months  4-6  (Second  Inter-measurement  Period.  Patients  will  have  the  timing  of 
their  low  dose  aspirin  reversed,  serving  as  their  own  controls  and  cross-overs.  Participants  who 
took  it  in  the  evening  will  now  take  it  in  the  morning  and  vice  versa.  Patients  will  be  contacted, 
encouraged  to  stay  consistent  with  the  protocol,  and/or  to  contact  Dr.  Kwon  or  study  staff.  The 
values  obtained  for  the  ABPM  and  the  fasting  labs  at  the  interim  evaluation  above  will  be  used 
also  for  the  baseline  for  the  second  inter-measurement  period. 

Final  Evaluation:  After  the  final  three  months  of  therapy  patients  will  return  for  a  fasting 
laboratory  sampling,  appointment  and  re-measurement  of  blood  pressure  to  include  another  48 
hour  AMBP.  Medical  records  will  be  reviewed  for  any  interim  visits,  hospitalizations,  or 
medication  changes.  Patients  will  be  asked  if  they  suffered  any  increase  in  side  effects  or 
gastrointestinal  discomfort  during  the  study  period. 

Progress:  This  study  was  delayed  for  five  months  prior  to  enrolling  patients.  Three  months 
following  initial  IRB  review,  the  Department  of  Nursing  made  multiple  reviews  of  the  study  prior 
to  releasing  their  impact  statement  in  support  of  this  study.  It  was  further  delayed  for  two  months 


209 


when  Clinical  Engineering  stated  that  the  necessary  equipment  could  not  be  held  or  utilized  at  the 
hospital  for  the  allotted  timeframe  of  the  study.  After  a  lengthy  debate  and  review  of  the 
CRADA/SOW,  Clinical  Engineering  approved  the  equipment  for  use  at  MAMC.  No  subjects 
enrolled  during  FY06. 


210 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205038  Status:  Terminated 

Title:  Effect  of  A  Single  Intra-articular  Steroid  Injection  on  Serum  Fructosamine  Levels  in 
Patients  with  Type  2  Diabetes  Mellitus 

Principal  Investigator:  CPT  George  R.  Mount,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  CPT  Cristin  A.  Kiley,  MC;  MAJ  Brian  T.  McKinley,  MC;  CPT  Kyle 
C.  Harner,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/3/2005  -  Jan  2006  DCI  N/A 

Study  Objective:  The  primary  objective  of  this  study  is  to  observe  the  effect  that  a  single  dose  of 
corticosteroid  (40mg  kenalog,  lcc)  injected  into  the  knee  joint  has  on  the  serum  glucose  level  in 
individuals  with  type  2  diabetes  mellitus. 

Technical  Approach:  Subjects  presenting  to  the  Rheumatology  clinic  for  intra-articular  steroid 
injection  into  the  knee,  who  have  Diabetes  Mellitus  and  are  not  currently  taking  insulin  therapy 
will  be  deemed  eligible  for  the  study.  Subjusts  who  meet  the  criteria  will  offered  consented.  If  they 
do  wish  to  participate,  the  consent  form  will  be  signed  and  the  patient  will  receive  their  joint 
injection.  Subjects  will  report  to  the  lab  immediately  after  joint  injection  for  Fructosamine  level 
and  HbAlc.  Subjects  will  return  to  the  lab  in  two  weeks  for  Fructosamine  level.  Subjects  will 
return  to  the  lab  in  two  weeks  (4  weeks  from  time  of  injection)  for  Fructsamine  level  and  HbAlc. 
Subject  participation  will  be  complete  at  this  time.  Lab  results  will  be  gathered  by  the 
investigators  and  the  data  will  be  analyzed. 

Progress:  This  protocol  was  terminated  by  investigators  in  June  2006  due  to  a  lack  of  accrual. 


211 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202048  Status:  Ongoing 

Title:  A  Multinational,  Randomized,  Double-blind,  Placebo-controlled,  Forced-titration,  2X2 

Factorial  Design  Study  of  the  Efficacy  and  Safety  of  Long  Term  Administration  of  Nateglinide 

and  Valsartan  in  the  Prevention  of  Diabetes  and  Cardiovascular  Outcomes  in  Subjects  with 

Impaired  Glucose  Tolerance  (IGT),  Protocol  No.  CDJN608  B2302 

Principal  Investigator:  MAJ  Patricia  A.  Short,  MC 

Department:  Medicine/Internal  Medicine  Facility:  MAMC 

Associate  Investigator(s):  LTC  Jon  C.  Allison,  MC;  Marvin  Y.  Hayami,  M.D.;  MAJ  Cecily  K. 

Peterson,  MC;  Shaila  B.  Kode,  M.D. 

Start  -  Completion:  Funding:  Periodic  Review: 

4/19/2002  -  Aug  2009  Novartis  via  Henry  M.  Jackson  Foundation  1/24/2006 

Study  Objective:  Core  Phase:  to  evaluate  the  effect  of  long-term  administration  of  nateglinide 
and  valsartan  on  the  progression  to  diabetes  in  subjects  with  impaired  glucose  tolerance  (IGT)  at 
increased  risk  of  a  cardiovascular  event.  Extension  Phase:  to  evaluate  the  effect  of  long-term 
administration  of  nateglinide  and  valsartan  on  cardiovascular  morbidity  and  mortality.  Definition 
of  this  composite  endpoint  is  provided  on  page  11  of  the  attached  Protocol,  and  is  further  discussed 
in  the  Summary  to  this  cover  document. 

Technical  Approach:  Approximately  24  subjects  will  be  enrolled  at  MAMC.  Study  design 
projects  enrollment  of  7500  subjects  from  600-800  centers  in  about  40  countries,  with 
approximately  1875  subjects  in  each  of  4  treatment  groups.  75%  of  subjects  will  receive  at  least 
one  of  the  study  drugs.  All  study  drugs  are  taken  orally.  Patients  will  be  invited  to  participate  in 
screening  who  have  one  or  more  risk  factors  for  the  conditions  under  study  (such  as  family  history, 
known  IGT,  high  BMI,  dyslipidemia.)  Eligible  patients  will  be  randomized  into  one  of  four  groups 
(1.  Nateglinide  60  mg  before  meals  +  matching  placebo  once  daily;  2.  Nateglinide  60mg  before 
meals  +  Valsartan  160mg  once  daily;  3.  Matching  placebo  before  meals  +  matching  placebo  once 
daily;  4.  Matching  placebo  before  meals  +  Valsartan  160mg  once  daily)  using  an  electronic 
interactive  voice  recognition  system.  There  will  be  sixteen  study  visits  after  initiation  of  study 
treatment:  at  +2  weeks,  +4  weeks,  +3  months,  +6  months,  then  visits  will  be  every  6  months. 
Patients  will  arrive  fasting,  scheduled  between  7- 10am.  Weight,  blood  pressure,  heart  rate  and 
blood  sampling  is  performed  at  each  visit.  A  urine  specimen  will  be  collected  at  3  time  points.  An 
ECG,  (electrocardiogram)  is  performed  at  the  second  visit  and  repeated  twice  during  the  study. 

The  OGTT  with  FPG  and  insulin  level  is  completed  every  12  months  after  baseline,  at  month 
37(for  confirmation),  and  as  indicated  to  confirm  progression  to  diabetes.  Subjects  are  asked  to 
keep  a  diary  of  suspected  hypoglycemic  events  and  a  subset  of  patients  may  be  provided  a  blood 
glucose  monitor  to  record  these  occurrences.  This  study  will  include  life  style  intervention 
counseling  of  subjects  at  every  visit,  with  written  educational  materials  provided  by  the  study 
sponsor. 

Progress:  This  protocol  closed  to  patient  entry  26  November  2003,  with  five  subjects  enrolled. 
Three  subjects  continued  to  be  followed  at  MAMC  during  FY06. 


212 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204045  Status:  Ongoing 

Title:  A  Prospective,  multinational,  multicenter,  double-blind,  randomized,  active-controlled 
trial  to  compare  the  effects  of  Lotrel  (amlodipine/benazepril)  to  benazepril  and 
hydrochlorothiazide  combined  on  the  reduction  of  cardiovascular  morbidity  and  mortality  in 
patients  with  high  risk  hypertension,  Protocol  No.  CCIB002I2301:  ACCOMPLISH  (Avoiding 
Cardiovascular  Events  through  COMbination  Therapy  in  Patients  Living  with  Systolic 
Hypertension) 

Principal  Investigator:  MAJ  Patricia  A.  Short,  MC 


Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jon  C.  Allison,  MC;  Michael  R.  Voorhies,  PAC 

Start  -  Completion:  Funding: 

4/7/2004  -  Oct  2009  SWOG  via  Henry  M.  Jackson  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  (1)  To  assess  the  time  to  first  event  of  composite  cardiovascular  morbidity  and 
mortality  with  amlodipine/benazepril  (Lotrel®)  compared  with  the  combination  of  benazepril  and 
hydrochlorothiazide  in  patients  with  high  risk  hypertension.  (2)  To  compare  composite 
cardiovascular  morbidity,  new  onset  diabetes,  progression  of  renal  disease  and  hospitalization  for 
congestive  heart  failure  with  amlodipine/benazepril  (Lotrel®)versus  the  combination  of  benazepril 
and  hydrochlorothiazide.  (3)  to  compare  all-cause  mortality,  all  hospitalizations,  renal  function 
(estimated  change  in  glomerular  filtration  rate),  LVH,  peripheral  arterial  revascularization 
procedure  or  nontraumatic  amputation  and  progression/regression  of  microalbuminuria  (30-300 
mg/g)  or  clinical  albuminuria  (>300  mg/g)  long  term  safety  and  tolerability  with 
amlodipine/benazepril  (Lotrel®)  versus  the  combination  of  benazepril  and  hydrochlorothiazide.  (4) 
To  identify  inherited  genetic  factors  which  may  be  related  to  hypertension,  predict  response  to 
treatment  with  the  study  medications,  predict  relative  susceptibility  to  drug-drug  interactions,  or 
predict  genetic  predisposition  to  serious  side  effects. 

Technical  Approach:  This  is  a  phase  III  randomized,  multicenter,  double-blind,  parallel-group, 
active-controlled  trial  comparing  the  efficacy  of  amlodipine/benazepril  combined  therapy  (Lotrel)  to 
the  combination  of  benazepril  and  hydrochlorothiazide  (HCTZ)  in  high  risk  hypertensive  subjects 
in  reducing  cardiovascular  outcomes.  20  subjects  may  be  enrolled  at  MAMC  with  approximately 
12,600  worldwide.  The  study  will  last  approximately  5  years,  including  the  18-month  recruitment 
period.  Eligible  subjects  will  be  randomized  in  1:1  ratio  to  one  of  two  groups  to  begin  blinded 
treatment  with  amlodipine/benazepril  5/20  mg  or  benazepril  20mg/HCTZ  12.5  mg.  The  study 
provides  for  dose-titration  followed  by  add-on  therapy  if  necessary  to  achieve  goal  blood  pressure 
(<140/<90  mmHg  or  lower  in  appropriate  subjects). 

Subjects  will  be  followed  every  4  weeks  up  to  3  months,  at  6  months,  and  every  6  months 
thereafter.  All  randomized  subjects  will  be  followed  until  study  completion,  including  those  who 
interrupt  or  discontinue  treatment.  Additional  visits  may  be  done  as  needed  to  ensure  blood 
pressure  control.  Patients  will  be  treated  in  the  study  until  the  required  number  of  randomized 
subjects  with  a  primary  cardiovascular  event  is  achieved  for  analysis.  Safety  and  efficacy 
assessments  will  consist  of  monitoring  pre-defined  non-serious  adverse  events,  all  serious  adverse 
events,  concomitant  medications,  regular  monitoring  of  hematology  and  blood  chemistry, 
urinalysis,  vital  signs  and  physical  examinations.  Observation  for  clinical  endpoints  will  be 
continuous.  Physical  exams  will  focus  on  cardiovascular  signs  and  symptoms.  12-lead  ECG  will  be 
performed  at  baseline,  month  18  and  year  3.  24-hour  ambulatory  blood  pressure  monitoring  at 
Year  2  will  be  done  in  a  subset  of  subjects.  Biomarker  tests  for  high  sensitivity  C-reactive  protein 
and  other  predictors  of  cardiovascular  disease  are  scheduled.  Subject  participation  in  a 
pharmacogenetics  sub-study  is  optional.  A  single  blood  specimen  will  be  collected  and  DNA  derived 

213 


from  the  sample  may  be  stored  and  studied  for  up  to  20  years  by  the  study  sponsor.  Interim 
analyses  for  monitoring  of  efficacy  demonstration  and  patient  safety  will  be  conducted  by  an 
independent  Data  Monitoring  Committee. 

Progress:  This  protocol  closed  to  enrollment  with  28  patients  consented,  17  enrolled.  Three 
subjects  have  discontinued  taking  study  medication  and  all  17  continued  to  be  followed  during 
FY06. 


214 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205004 

Status:  Completed 

Title:  Efficacy  of  Iron  in  Restless  Legs  Syndrome  (RLS)  Patients  With  Low-Normal  Ferritin:  A 
Randomized,  Double-Blind,  Placebo  Controlled  Study 

Principal  Investigator:  CPT  Jam7es  Y.  Wang,  MC 

Department:  Medicine/Internal  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Angela  G.  Mysliwiec,  MC; 

CPT  Collin  J.  Fischer,  MC 

Start  -  Completion:  Funding: 

1/31/2005  -  Aug  2005  DCI 

Periodic  Review: 

10/25/2005 

Study  Objective:  To  determine  the  efficacy  of  treating  RLS  patients  who  have  low-normal 
ferritin  with  oral  ferrous  sulfate. 


Technical  Approach:  This  is  a  double  blinded  placebo-controlled  study  of  iron  in  RLS  patients 
that  have  a  low-normal  ferritin  level  (12-100mcg/l).  Adult  patients  (age  >  18)  that  meet  the 
International  RLS  Study  group  diagnostic  criteria  for  RLS  will  be  consented  to  have  a  ferritin,  iron 
panel,  and  CBC  checked.  Those  who  have  concurrent  ferritin  in  the  low-normal  range  (12-100mg/l) 
and  at  least  moderately  severe  symptoms  according  to  the  IRLSSG  rating  scale  for  RLS  will  be 
eligible  for  the  study.  Sample  size  will  be  between  9-39  patients  in  each  treatment  group  for  a  total 
of  18-78  patients.  These  patients  will  be  randomized  to  treatment  with  325mg  iron  twice  a  day  by 
mouth  or  placebo.  Patients  will  have  follow  up  at  6  and  12  weeks  post  treatment.  Outcome  will  be 
measured  by  improvement  in  overall  score(decrease  in  total  score  by  least  5  points)  on  the  IRLSSG 
RLS  validated  severity  survey  from  pre-treatment  to  12  weeks  post  treatment  and  a  statistical 
improvement  of  treatment  group  vs.  placebo  using  the  T  test  for  independent  samples.  An 
additional  endpoint  measurement  will  be  overall  improvement  in  quality  of  life  after  treatment. 
Patients  will  be  treated  for  a  total  of  12  weeks  in  this  trial. 

Progress:  This  protocol  was  reported  completed  in  June  2006,  with  38  subjects  consented. 
Seventeen  subjects  completed  the  study,  two  left  the  area  before  completing,  one  did  not  think  iron 
would  benefit  him,  and  eighteen  screen-failed.  No  patients  had  significant  adverse  side  effects 
from  the  study  medication.  Preliminary  data  analysis  suggests  that  treating  RLS  patients  with 
low- normal  ferritin  with  PO  iron  may  improve  RLS  symptoms  and  overall  quality  of  life. 


215 


Detail  Summary  Sheets 

Nephrology  Service,  Department  of  Medicine 


216 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205121 

Status:  Completed 

Title:  Does  High  Resistive  Index  by  Doppler  Ultrasonography  Predict  Small  Kidney  Sizes? 

Principal  Investigator:  MAJ  Joseph  Y.  Lee,  MC 

Department:  Medicine/Nephrology 

Facility:  MAMC 

Associate  Investigator(s):  CPT  David  Owshalimpur,  MC 

Start  -  Completion:  Funding: 

8/18/2005  -  Dec  2005  DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  retrospectively  determine  if  high  resistive  indices  by  Doppler 
ultrasonography  is  predictive  of  small  kidney  sizes. 


Technical  Approach:  This  study  is  a  retrospective  review  and  data  analysis  of  up  to  400  Doppler 
ultrasound  reports  in  the  Vascular  Clinic  Lab  database.  Data  recorded  will  include  age,  sex, 
percentage  of  renal  artery  stenosis  (as  reflected  by  aorta/renal  artery  velocity  ratios),  resistive 
index  and  kidney  sizes.  A  review  of  ICDB  medical  records  will  be  done  to  exclude  the  reports  from 
patients  who  have  a  single  kidney,  diabetes,  or  infiltrative/cystic  kidney  disease.  The  control  group 
will  be  ultrasound  reports  of  patients  who  have  no  significant  renal  artery  stenosis  (>60%)  or  high 
resistive  index  (>80%).  The  resistive  indices  and  kidney  sizes  will  be  grouped  by  age  into  this 
range:  <30,  31-60,  and  >60.  The  control  group  will  be  divided  the  same  way.  Descriptive  statistics 
will  be  used  to  summarize  the  overall  sample.  A  correlation  coefficient  will  be  used  to  compare 
high  resistive  index  to  kidney  size.  Student's  T-test  will  be  used  to  compare  mean  kidney  size  of 
those  with  and  without  renal  artery  stenosis.  A  regression  analysis  will  be  used  to  determine  the 
influence  of  resistive  index,  age,  serum  creatinine,  GFR,  and  renal  artery  stenosis  on  kidney  size. 

Progress:  This  protocol  was  reported  completed  in  April  2006.  Results:  There  was  no  correlation 
between  high  renal  resistive  index  and  kidney  size;  nor  any  correlation  between  age,  serum 
creatinine  and  male  gender  with  kidney  size.  Both  advancing  age  and  serum  creatinine  were  found 
to  have  smaller  kidneys,  while  male  gender  compared  to  female  gender  had  larger  kidneys. 
Conclusion:  This  retrospective  study  did  not  show  a  correlation  between  renal  resistive  index,  an 
indirect  measure  of  small  vessel  kidney  disease  presumed  to  be  caused  by  kidney  sclerosis  and 
kidney  size. 


217 


Detail  Summary  Sheets 

Neurology  Service,  Department  of  Medicine 


218 


Detail  Summary  Sheet 

Date:  30  Sep  06 

Number:  204062 

Status:  Ongoing 

Title:  A  Randomized  Trial  of  a  Migraine  Management  Seminar 

Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

in  the  Treatment  of  Migraines 

Department:  Medicine/Neurology 

Facility:  MAMC 

Associate  Investigator(s):  COL  Beverly  R.  Scott,  MC;  Joan  L.  Wilson,  MSW;  CPT  Douglas  R. 
Langford,  MC 

Start  -  Completion: 

4/15/2004  -  Mar  2006 

Funding: 

DCI 

Periodic  Review: 

3/28/2006 

Study  Objective:  To  determinie  the  effectiveness  of  a  migraine  management  seminar  for 
improving  migraine  headaches,  migraine-associated  disability  and  migraine-related  quality  of  life. 


Technical  Approach:  Subjects  will  attend  a  unique,  3-hour,  single-session  seminar  to  augment 
the  medical  management  of  migraine  headaches.  The  seminar  will  educate  subjects  with 
migraines  about  their  disorder  and  various  treatments  and  teach  practical  non-pharmacologic 
migraine  management  skills.  The  study  is  a  randomized,  controlled,  single-center  trial  to 
determine  the  efficacy  of  a  migraine  management  seminar,  when  used  as  adjunctive  therapy  to 
standard  medical  therapy  in  the  treatment  of  migraine  headaches.  Eighty  subjects,  fulfilling  the 
International  Headache  Society  criteria  for  migraines  and  suffering  from  significant  migraine 
associated  disability  will  be  enrolled  in  the  study.  Subjects  will  be  recruited  from  consecutive 
subjects  referred  to  the  MAMC  Neurology  Clinic  for  headache  consultation.  Study  subjects  will  be 
randomized  to  medical  therapy  (control  group)  or  medical  therapy  in  combination  with  the 
migraine  management  seminar  (treatment  group).  Medical  therapy  will  be  determined  by  each 
subject's  consulting  neurologist,  will  conform  to  standard  of  care  for  the  treatment  of  migraine  and 
not  be  constrained  or  otherwise  influenced  by  the  study.  All  subjects  will  record  a  standardized 
headache  diary  during  the  study  period.  The  primary  outcome  measures  are  number  of  headache 
days  per  month  and  change  in  the  Migraine  Disability  Assessment  (MIDAS)  score.  Secondary 
outcomes  include  the  Migraine  Specific  Quality  of  Life  (MSQOL)  questionnaire  score,  migraine 
severity  and  duration,  healthcare  utilization  and  a  migraine  management  satisfaction  survey. 
Outcomes  will  be  assessed  at  baseline,  3  months  after  randomization  and  6  months  after 
randomization. 

Progress:  This  protocol  is  open  to  enrollment  52  patients  enrolled  at  MAMC.  Twenty-six  (26) 
patients  have  completed  the  study,  seventeen  remain  actively  enrolled,  and  nine  were  lost  to 
follow-up.  There  have  been  no  adverse  outcomes.  No  data  analysis  has  been  done. 


219 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203048 

Status:  Ongoing 

Title:  A  Randomized  Trial  of  B  Vitamins  for  Alzheimer's  Disease 

Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

Department:  Medicine/Neurology 

Facility:  MAMC 

Associate  Investigator(s):  COL  Frederick  G.  Flynn,  MC 

Start  -  Completion:  Funding: 

6/8/2004  -  Mar  2005  Upsher-Smith  Laboratories  via  Henry  M. 

Jackson  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  To  determine  whether  B  vitamin  supplements  improve  cognitive  function  in 
patients  with  mild-to-moderate  Alzheimer's  disease. 


Technical  Approach:  To  test  the  hypothesis  that  B  vitamin  supplements  improve  cognitive 
function  in  patients  with  Alzheimer's  disease,  80  patients  with  mild-to-moderate  Alzheimer's 
disease  will  be  enrolled  in  a  prospective,  randomized,  open-label  trial.  Subjects  will  be  randomized 
to  receive  B  vitamin  supplements  consisting  of  vitamin  B12  (0.5  mg  qd),  vitamin  B6  (50  mg  qd), 
and  folate  (2  mg  qd)  or  no  B  vitamin  supplements  over  a  period  of  1  year.  Cognitive  function,  as 
measured  by  the  Alzheimer's  Disease  Assessment  Scale  (ADAS),  will  be  measured  at  baseline  and 
then  after  3  months,  6  months,  and  12  months  of  treatment.  The  primary  outcome  will  be  change 
in  ADAS  score  compared  to  baseline.  Analysis  of  variance  will  be  used  to  test  for  significant 
differences  between  the  two  treatment  groups. 

Progress:  This  protocol  remains  open  to  enrollment,  with  six  subjects  enrolled,  one  during  FY06. 
Five  subjects  have  completed  participation,  and  one  subject  continued  to  be  followed.  No  adverse 
events  have  occurred. 


220 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206075  Status:  Ongoing 

Title:  Association  Between  Migraine  and  Psychiatric  Conditions  In  Soldiers  Returning  from 
Combat 

Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

Department:  Medicine/Neurology  Facility:  MAMC 

Associate  Investigator(s):  COL  Gregory  A.  Gahm,  MS;  Barbara  A.  Lucenko,  PhD; 

Start  -  Completion:  Funding:  Periodic  Review: 

4/4/2006  -  Dec  2006  DCI  N/A 

Study  Objective:  Objectives:  To  determine  the  prevalence  of  post-traumatic  stress  disorder 
(PTSD)  among  Soldiers  with  and  without  migraine  headaches,  to  determine  the  prevalence  of 
depression  among  Soldiers  with  and  without  migraine  headaches,  to  determine  the  association 
between  PTSD  and  migraine  outcomes  in  Soldiers,  and  to  determine  the  association  between 
depression  and  migraine  outcomes  in  Soldiers. 

Technical  Approach:  PHQ-9  and  PC-PTSD  scores  will  be  obtained  from  the  SWAP  database  for 
each  subject  enrolled  in  the  migraine  screening  database.  A  single  database  will  be  constructed. 

Progress:  This  protocol  is  closed  to  patient  entry,  with  a  total  of  2,605  subjects  enrolled  in  this 
cross-sectional,  observational  study.  The  protocol  remains  ongoing  for  data  analysis. 


221 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203097  Status:  Ongoing 

Title:  CLOSURE  I  Trial:  A  Prospective,  Multicenter,  Randomized,  Controlled  Trial  to  Evaluate 
the  Safety  and  Efficacy  of  the  STARFlex  Septal  Closure  System  Versus  Best  Medical  Therapy  in 
Patients  with  a  Stroke  and/or  Transient  Ischemic  Attack  Due  to  a  Presumed  Paradoxical 
Embolism  Through  a  Patent  Foramen  Ovale 

Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 


Department:  Medicine/Neurology 

Facility:  MAMC 

Associate  Investigator(s):  COL  Beverly  R.  Scott,  MC;  COL  David  T.  Schachter,  MC;  CPT  Erek 
K.  Helseth,  MC 

Start  -  Completion:  Funding: 

9/18/2003  -  Oct  2006  NMT  Medical,  Inc  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

6/27/2006 

Study  Objective:  To  determine  whether  the  STARFlex  Septal  Closure  System  (STARFlex)  will 
safely  and  effectively  prevent  recurrent  embolic  stroke/transient  ischemic  attack  (TIA)  and 
mortality  in  patients  with  a  patent  foramen  ovale  (PFO)  and  to  demonstrate  superiority  of  the 
STARFlex  device  compared  to  best  medical  therapy. 

Technical  Approach:  The  STARFlex  Septal  Closure  System  is  an  investigational  device  for  non- 
surgical,  transcatheter  closure  of  intracardiac  defects.  The  CLOSURE  I  Trial  is  a  prospective, 
multicenter,  randomized,  controlled  trial  to  evaluate  the  safety  and  efficacy  of  the  STARFlex 
System  in  preventing  recurrent  cerebrovascular  events  in  patients  with  a  PFO.  The  study  will 
enroll  MAMC  patients  18  to  60  years  of  age  who  have  had  a  documented  stroke  or  TIA  within  the 
last  3  months,  have  a  PFO  as  detected  by  transesophageal  echocardiography  (TEE)  with  saline 
contrast  bubble  study,  and  do  not  have  any  other  potentially  embolic  source  or  other  cause  of 
stroke  or  TIA.  Up  to  15  patients  will  be  enrolled  at  MAMC  and  a  total  of  1600  patients  will  be 
enrolled  at  120  centers  in  the  United  States.  Investigators  will  receive  training  in  use  of  the 
device.  Patients  will  be  randomized  to  receive  implantation  of  the  STARFlex  device  with 
concomitant  aspirin  therapy  or  medical  therapy  consisting  of  aspirin  and/or  coumadin.  Patients 
who  have  device  implantation  will  also  be  treated  with  clopidogrel  (Plavix)  75mg  daily  for  6 
months.  All  patients  will  undergo  serial  physical  exams,  EKGs,  and  neurological  evaluations  (to 
detect  recurrent  stroke  or  TIA)  at  6  months,  12  months,  and  24  months  after  device  implantation 
or  initiation  of  medical  therapy.  Patients  who  receive  the  device  will  also  have  a  transesophageal 
echocardiogram  with  saline  contrast  bubble  study  and  chest  x-ray  6  months  after  implantation  to 
assess  for  closure  of  the  PFO  and  condition  of  the  device.  The  primary  endpoints  of  the  study  are 
the  2-year  incidence  of  stroke/TIA  and  all  cause  mortality.  Data  will  be  analyzed  on  an  intent-to- 
treat  basis  using  the  chi-square  test  and  logistic  regression.  A  central  Data  and  Safety  Monitoring 
Board  will  inspect  and  make  recommendations  regarding  rate  of  stroke/TIA  at  approximately  10 
months  and  18  months  after  start  of  the  study  for  efficacy  or  safety  concerns. 

Progress:  This  protocol  remains  open  to  enrollment  with  three  volunteers  enrolled  in  the  last 
twelve  months,  bringing  the  total  number  of  enrolled  subjects  to  eight.  Four  subjects  were 
randomized  to  the  STARflex  device  arm  and  four  subjects  were  randomized  to  the  medical  therapy 
arm.  Two  subjects  have  moved  away  from  the  area  and  will  complete  study  participation  at 
another  research  site.  Six  subjects  continued  to  be  followed  at  MAMC  during  FY06.  The  STARflex 
device  became  dislodged  in  one  subject  during  the  implantation  procedure,  requiring  surgical 
removal,  but  there  were  no  long-term  complications. 


222 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205107  Status:  Completed 

Title:  Diagnosis  and  Treatment  of  Migraines  in  U.S.  Army  Soldiers 
Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

Department:  Medicine/Neurology  Facility:  MAMC 

Associate  Investigator(s):  CPT  Douglas  R.  Langford,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/21/2005  -  Sep  2005  DCI  N/A 

Study  Objective:  (1)  To  determine  the  proportion  of  soldiers  with  migraines  whose  headaches  are 
diagnosed  as  migraines  prior  to  neurology  consultation.  (2)  To  determine  the  prevalence  of 
analgesic  overuse  among  soldiers  with  migraine.  (3)  To  determine  the  medical  treatment  provided 
to  soldiers  with  migraines. 

Technical  Approach:  A  retrospective  chart  review  will  be  performed  to  determine  the  patterns  of 
medical  care  provided  to  Army  soldiers  with  migraine  headaches.  The  charts  of  50  consecutive 
active  duty  Army  soldiers  meeting  International  Headache  Society  diagnostic  criteria  for  migraine 
headaches  who  were  evaluated  in  the  MAMC  neurology  clinic  in  2004  will  be  reviewed.  Diagnosis 
and  treatments  prior  to,  and  after,  neurology  consultation  will  be  compared.  Endpoints  will  include 
the  proportions  of  patients  diagnosed  with  migraine,  treated  with  prophylactic  medications, 
treated  with  triptan-class  medications,  and  treated  with  non-pharmacologic  treatments. 

Progress:  A  total  of  50  Soldiers  participated.  A  diagnosis  of  migraine  was  made  in  42%  of  patients 
prior  to  neurology  referral  and  in  100%  upon  neurology  consultation  (p<0.001).  Analgesic  overuse 
was  diagnosed  in  0%  of  patients  before  neurology  consultation  and  in  23%  at  the  time  of  neurology 
consultation  (p<0.001).  63%  of  eligible  patients  were  treated  with  a  prophylactic  medication  prior 
to  neurology  referral  compared  to  100%  after  neurology  consultation  (p<0.01).  Prior  to  neurology 
referral,  acute  migraine  treatment  using  combination  analgesics  or  opioids  was  significantly  more 
common  (p<0.001)  and  treatment  using  a  triptan  medication  was  significantly  less  common 
(p=0.003).  Non-pharmacologic  treatments  for  migraine  were  used  in  4%  of  patients  before 
neurology  referral  and  in  52%  after  neurology  consultation. 

Conclusions:  Migraine  headaches  are  frequently  undiagnosed  in  Soldiers  prior  to  neurology 
consultation.  Concomitant  analgesic  overuse  affects  nearly  one  quarter  of  Soldiers  with  migraines 
at  the  time  they  are  first  seen  in  neurology,  but  is  rarely  recognized  prior  to  referral.  Soldiers  with 
migraines  are  less  likely  to  be  treated  with  prophylactic  medication,  migraine-specific  medications, 
or  non-pharmacologic  treatments  prior  to  neurology  consultation.  Improving  the  ability  of  first- 
line  providers  to  diagnose  and  treat  migraine  will  reduce  the  burden  of  this  disorder  in  Soldiers 
and  thus  enhance  military  readiness. 


223 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205118  Status:  Ongoing 

Title:  Prevalence  and  Impact  of  Migraine  Among  Deployed  Soldiers 
Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

Department:  Medicine/Neurology  Facility:  MAMC 

Associate  Investigator(s):  CPT  Brett  J.  Theeler,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/5/2005  -  Dec  2005  DCI  7/18/2006 

Study  Objective:  (1)  To  determine  the  prevalence  of  migraine  among  soldiers  during  military 
deployment.  (2)  To  determine  the  frequency  and  severity  of  migraine  headaches  among  deployed 
soldiers.  (3)  To  determine  the  impact  of  migraines  on  soldier  readiness  during  deployment.  (4)  To 
determine  the  diagnosis  and  treatment  patterns  of  migraine  among  deployed  soldiers. 

Technical  Approach:  This  is  a  cross-sectional,  observational,  questionnaire  based  study  to 
determine  the  prevalence,  impact,  and  treatment  patterns  of  migraine  among  soldiers  during 
military  deployment.  Approximately  3,000  soldiers  of  the  1st  Stryker  Brigade  will  be  asked  to 
voluntarily  complete  a  standardized,  validated,  headache  questionnaire  during  their  post¬ 
deployment  health  evaluation.  The  questions  on  the  questionnaire  are  based  on  the  diagnostic 
criteria  of  migraine,  headache  frequency,  headache-related  disability,  and  headache  treatments. 
Responses  will  be  used  to  calculate  the  prevalence,  frequency,  severity,  and  duration  of  migraines 
among  deployed  soldiers.  The  extent  to  which  migraines  impede  performance  of  military  duties 
and  current  treatment  patterns  for  migraine  among  this  population  will  also  be  determined. 
Dependent  variables  include:  proportion  of  soldiers  experiencing  one  or  more  migraine  headaches 
during  deployment;  mean  number  of  headache  days  per  month;  mean  duration  and  severity  of 
headaches;  number  of  missed  and  sub-optimal  duty  days  attributable  to  headache;  proportion  of 
soldiers  with  migraine  who  were  previously  diagnosed  by  a  healthcare  provider  and  proportion  of 
soldiers  with  migraine  who  used  migraine -specific  medications  during  deployment. 

Progress:  The  study  questionnaire  was  completed  by  2,725  Soldiers;  377  Soldiers  with  migraines 
subsequently  completed  a  follow-up  questionnaire  three  months  later.  Data  analysis  is  almost 
complete.  Preliminary  results  were  presented  at  the  American  Headache  Society  meeting  24  June 
2006. 


224 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205115  Status:  Ongoing 

Title:  Study  of  Acute  Viprinex™  for  Emergency  Stroke:  A  Randomized,  Double-Blind,  Placebo- 
Controlled  Study  of  Viprinex™  (Ancrod  Injection)  in  Subjects  Beginning  Treatment  within  6 
Hours  of  the  Onset  of  Acute,  Ischemic  Stroke 

Principal  Investigator:  MAJ  Jay  C.  Erickson,  MC 

Department:  Medicine/Neurology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Robert  B.  Blankenship,  MC;  MAJ  Anna  D.  Hohler,  MC;  CPT 
Jessica  D.  Lee,  MC;  CPT  Douglas  R.  Langford,  MC;  MAJ  Jason  A.  Friedman,  MC;  CPT  Erek  K. 
Helseth,  MC;  COL  Beverly  R.  Scott,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/9/2005  -  Sep  2007  Neurobiological  Technologies,  Inc.  via  Henry  7/20/2006 

M.  Jackson  Foundation 

Study  Objective:  To  determine  whether  ancrod  (Viprinex™)  begun  intravenously  within  6  hours 
of  stroke  onset  confers  statistically  benefit  in  reducing  the  incidence  of  disability  at  90  days 

Technical  Approach:  This  is  a  phase  III,  double-blind,  placebo  controlled  study  to  that  will  be 
conducted  by  the  Neurology/Stroke  Team  service  at  MAMC.  Up  to  10  subjects  may  be  enrolled;  a 
total  of  500  enrolled  in  the  study  overall.  Eligible  subjects  will  present  to  the  ER  with  the 
diagnosis  of  a  stroke  and  symptom  onset  within  6  hours  before  the  Ancrod  infusion.  If  patients  are 
eligible  to  receive  rt-PA,  they  will  not  be  enrolled  in  this  study.  Subjects  will  have  a  routine  history 
and  physical,  neurological  examination,  laboratory  tests,  a  non-contrast  CT  scan,  and  a  12  lead 
ECG.  Subjects  will  be  randomized  to  one  of  two  treatment  groups  in  a  biased-coin  approach  using 
study-wide  balanced  enrollment  in  the  two  treatment  groups  by  age  category  (<65,  65-75,  >75), 
independent  of  stratum  assignment.  Randomization  will  be  completed  via  an  interactive  voice 
response  system.  Subjects  will  receive  the  3  hour  transfusion  and  continue  to  have  follow-up  after 
discharge  until  90  days  after  being  treated  with  study  medication. 

Progress:  This  protocol  remains  open  to  patient  entry.  No  patients  have  met  enrollment  criteria. 
Study  staff  continues  to  actively  screening  all  acute  stroke  patients. 


225 


Detail  Summary  Sheets 

Pulmonary  Disease  &  Critical  Care  Service, 

Department  of  Medicine 


226 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205032 

Status:  Terminated 

Title:  Adjunctive  Role  of  Mirtazapine  in  Mild  Positional  Sleep  Apnea 

Principal  Investigator:  LTC  (Ret)  William  E.  Caras,  M.D. 

Department:  Medicine/Pulmonary  &  Critical  Care 

Facility:  MAMC 

Associate  Investigator(s):  COL  Bernard  J.  Roth,  MC;  MAJ  Vincent  Mysliwiec,  MC;  Larry  G. 
Knauss,  Ph.D. 

Start  -  Completion:  Funding: 

Periodic  Review: 

10/11/2005  -  Nov  2005  Oraganon  via  The  Geneva  Loundation 

1/18/2006 

Study  Objective:  This  study  plans  to  look  at  the  adjunctive  role  of  Mirtazapine,  an 
antidepressant  with  sleep  enhancing  qualities,  to  positional  therapy  (PST)  in  patients  with  mild 
positional  OSA. 


Technical  Approach:  This  is  a  prospective  randomized  placebo  controlled  trial.  30  subjects  will 
be  enrolled  following  screening  and  randomized  to  receive  active  drug  or  placebo.  Both  groups  will 
be  asked  to  complete  a  sleep  diary.  PSG  variables  will  be  total  sleep  time,  sleep  efficiency,  sleep 
latency,  Stage  1  sleep,  Stage  2  (min)  Stage  3(min),  Rem  (min),  Rem  latency  (min).  Amended:  Jan 
2006,  to  an  open,  sequential  design  to  allow  all  potential  patients  to  enroll  in  the  1st  phase  of  the 
study,  which  will  use  only  the  positional  sleep  vest.  After  a  month  of  treatment  patients  will  be 
reassessed  and  then  may  chose  to  enroll  in  the  2nd  phase  of  the  study  combining  the  sleep  vest 
with  Mirtazapine. 

Progress:  This  study  was  amended  in  January  2006,  to  an  open,  sequential  design  to  allow  all 
potential  patients  to  enroll  in  the  first  phase  of  the  study  using  only  the  positional  sleep  vest.  After 
a  month  of  treatment  patients  would  be  reassessed  and  then  may  chose  to  enroll  in  the  second 
phase  of  the  study  combining  the  sleep  vest  with  Mirtazapine.  However,  Dr.  Caras  eventually 
terminated  the  study  due  to  lack  of  accrual  citing  patient's  deep  seated  reluctance  to  take  a 
medication  known  as  an  antidepressant. 


227 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206083  Status:  Terminated 

Title:  A  Randomized,  Double-blind,  Placebo-controlled,  Parallel  Group,  Stratified,  Multi-center, 
12  Week  Study  Comparing  the  Safety  and  Efficacy  of  Fluticasone  and  Formoterol  Combination 
(FlutiForm™  100/10  meg  twice  daily)  in  a  Single  Inhaler  (SkyePharma  HFA  pMDI)  with  the 
Administration  of  Placebo  or  Fluticasone  (100  meg  twice  daily)  and  Formoterol  (10  meg  twice 
daily)  Alone  in  Adolescent  and  Adult  Patients  with  Mild  to  Moderate  Asthma 

Principal  Investigator:  LTC  Cynthia  F.  Clagett,  MC 


Department:  Medicine/Pulmonary  &  Critical  Care 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Alexander  S.  Niven,  MC;  CPT  Katherine  A.  Simonson,  AN 

Start  -  Completion:  Funding: 

6/28/2006  -  Dec  2007  SkyePharma  via  Henry  M.  Jackson 

Foundation 

Periodic  Review: 

N/A 

Study  Objective:  The  primary  objective  is  to  demonstrate  the  efficacy  of  SKP  FlutiForm  HFA 
pMDI  compared  to  Fluticasone  propionate  and  Formoterol  fumarate  alone  and  placebo  when 
administered  by  inhalation  twice  daily  over  12  weeks  in  adult  patients  with  mild  to  moderate 
asthma.  (Only  subjects  18  years  or  older  with  mild  asthma  will  be  enrolled  at  MAMC) 

Technical  Approach:  All  eligible  patients  will  undergo  a  Run-In  Period  of  up  to  2  weeks 
depending  on  their  history  of  steroid  use.  Steroid-requiring  patients  will  undergo  a  Run-In  Period 
up  to  2  weeks  during  which  they  will  receive  asthma  maintenance  therapy  using  Fluticasone  HFA 
pMDI  (50  meg  twice  daily).  Steroid-free  patients  will  undergo  a  Run-In  Period  up  to  4  weeks 
during  which  they  will  not  receive  any  controlling  medication.  Use  of  rescue  Albuterol  pMDI  will 
be  permitted  for  all  patients  as  needed  for  the  control  of  worsening  asthma  symptoms  during  the 
Run-In  period.  At  the  Baseline  Visit  (Week  0)  following  the  Run-In  period,  eligible  patients  will  be 
randomized  to  the  treatment  groups.  Treatment  assignment  will  be  stratified  according  to  prior 
steroid  use  (steroid-requiring  versus  steroid  free).  Study  drug  will  be  administered  twice  daily  over 
a  12  week  period.  Patient  visits  will  occur  at  Weeks  2,  4,  8  and  12,  during  which  assessments 
(including  serial  PFTs  up  to  4  hours)  will  be  made.  During  the  Treatment  Period,  patients  may 
take  only  their  blinded  study  medication;  all  other  asthma  medications  will  be  withheld  for  the 
duration  of  the  Treatment  Period.  Use  of  the  rescue  Albuterol  pMDI  will  be  permitted  in  all 
patients  as  needed  during  the  Treatment  Period  for  control  of  worsening  asthma  symptoms. 

Progress:  This  protocol  was  terminated  21  September  2006,  due  to  failed  contract  negotiations 
with  the  study  sponsor.  The  study  was  never  initiated  at  MAMC. 


228 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206086  Status:  Ongoing 

Title:  Identifying  Adherence  Obstacles  to  CPAP  Therapy 
Principal  Investigator:  MAJ  Vincent  Mysliwiec,  MC 

Department:  Medicine/Pulmonary  &  Critical  Care  Facility:  MAMC 

Associate  Investigator(s):  Robert  D.  Swanson,  M.A.;  Suzette  Gagnon-Bailey,  RN;  Michael  J. 
Kuculyn;  Richard  D.  Guesford 

Start  -  Completion:  Funding:  Periodic  Review: 

5/8/2006  -  Aug  2007  DCI  N/A 

Study  Objective:  The  primary  objective  of  this  study  is  to  introduce  a  survey,  in  the  form  of  a 
Concerns  Questionnaire  that  will  assess  compliance  and  reasons  for  non-compliance  in  patients 
diagnosed  with  Obstructive  Sleep  Apnea  (OSA)  who  are  prescribed  Continuous  positive  airway 
pressure  (CPAP). 

Technical  Approach:  Subjects  with  OSA  that  will  be  treated  with  CPAP  will  be  identified  by 
treating  provider  and  scheduled  for  follow  up  within  3  months.  Subjects  will  return  for  follow  up 
with  the  downloaded  data  from  CPAP  machine  and  compliance  data  downloaded.  During  this  time 
patients  will  complete  the  "PAP  Concerns  Questionnaire."  The  downloaded  data  are  transferred  to 
"CPAP  Concerns  Questionnaire"  for  analysis. 

Progress:  Data  collection  is  complete  with  100  patients  who  utilize  CPAP  having  filled  out  the 
questionnaire  during  FY06.  Data  has  been  entered  into  a  excel  spread  sheet  and  is  ready  for 
interim  analysis.  At  this  point  we  plan  to  identify  which  specific  questions  are  statistically 
significant  in  determining  CPAP  compliance. 


229 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205128  Status:  Ongoing 

Title:  Impulse  Oscillometry  and  Obstructive  Lung  Disease:  Assessment  of  a  Clinically 

Significant  Bronchodilator  Response 

Principal  Investigator:  MAJ  Alexander  S.  Niven,  MC 

Department:  Medicine/Pulmonary  &  Critical  Care  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Steven  P.  Bennett,  MC;  LTC  Cynthia  L.  Clagett,  MC;  CPT 

Johathan  R.  Coyle,  MC;  Suzette  Gagnon-Bailey,  RN;  MAJ  William  F.  Kelly,  MC;  MAJ  Vincent 

Mysliwiec,  MC;  MAJ  John  P.  Rinard,  MC;  CPT  Charles  C.  Broy,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/14/2005  -  Sep  2008  Amarillo  Pulmonary  via  MAMC  9/26/2006 

Study  Objective:  This  study  will  (1)  evaluate  asymptomatic  nonsmokers  using  impulse 
oscillometry  (IOS)  and  conventional  pulmonary  function  tests  before  and  after  bronchodilator 
administration  to  determine  the  normal  adult  bronchodilator  IOS  responses  to  albuterol  and  (2) 
evaluate  the  ability  and  extent  to  which  IOS  can  identify  airway  changes  in  asymptomatic 
smokers,  patients  with  asthma  and  chronic  obstructive  lung  disease  (COPD)  compared  to  standard 
pulmonary  function  testing. 

Technical  Approach:  89  asymptomatic  nonsmoker  volunteers  will  be  recruited  from  the  hospital 
staff.  89  asymptomatic  smokers  will  be  recruited  from  the  hospital  staff  and  family  members  of 
patients  visiting  Madigan  AMC  for  medical  appointments.  Based  on  prior  literature  suggesting 
that  50%  of  asthmatics  and  10-15%  of  COPD  patients  will  have  evidence  of  reversible  airway 
obstruction,  178  asthmatics  and  890  patients  with  COPD  will  need  to  be  enrolled  to  examine  this 
important  variable.  These  subjects  will  be  recruited  from  routine  outpatient  referrals  to  the 
Pulmonary  Function  Lab  for  clinical  testing. 

All  asymptomatic  subjects  will  complete  a  questionnaire  on  their  demographics,  medical  and 
smoking  history,  and  a  review  of  systems  to  confirm  the  absence  of  cardiopulmonary  complaints. 
Height,  sitting  height,  and  weight  will  be  measured  in  each  subject.  Four  IOS  measurements  of  60- 
90  seconds  each  will  be  performed  followed  by  standard  spirometry  and  lung  volume 
measurements.  Each  subject  will  receive  3  inhalations  of  albuterol  90  micrograms  using  a  spacer 
device  and  repeat  the  IOS,  spirometry,  and  lung  volume  measurements  after  10  minutes.  Subjects 
with  asthma  and  COPD  will  undergo  the  same  protocol,  with  the  addition  of  completing  a 
validated  asthma  or  COPD  questionnaire  to  evaluate  the  severity  and  impact  of  their  respiratory 
disease  on  their  daily  activities. 

The  primary  outcome  variables  for  IOS  will  include  the  respiratory  impedance  (Zrs),  respiratory 
resistance  at  5,  15,  and  20  Hz  (R5,  R15,  R20),  frequency  dependence  from  5-15  Hz  and  5-20  Hz 
(R5-15,  R5-20),  the  respiratory  reactance  at  5  Hz  (X5)  and  the  reactance  area  (AX),  the  resonant 
frequency  (frs)  before  and  after  bronchodilator  administration.  The  primary  outcome  variables  for 
conventional  pulmonary  function  testing  will  be  the  forced  vital  capacity  (FVC),  the  forced 
expiratory  volume  in  1  second  (FEV1)  and  6  seconds  (FEV6),  the  ratio  of  FEV1  to  FVC,  body 
plethysmography  measurements  for  functional  residual  capacity  (FRO),  inspiratory  capacity  (IC), 
and  vital  capacity  (VC)  before  and  after  bronchodilator  administration.  Summary  statistics, 
frequency  and/or  contingency  tables  will  be  provided  for  all  variables  of  the  study.  Baseline  and 
post-bronchodilator  IOS  variables  will  be  correlated  to  conventional  pulmonary  function 
measurements  using  a  paired  t  test.  The  impact  of  variables  age,  height,  sitting  height,  race, 
gender,  and  allergy  symptoms  will  be  evaluated  using  the  Analysis  of  Variance  (ANOVA)  and  the 
Multivariate  Analysis  of  Variance  (MANOVA).  Comparison  between  measurements  obtained  in 
asymptomatic  nonsmokers  and  measurements  obtained  in  asymptomatic  smokers,  asthmatics  and 


230 


COPD  subjects  will  be  performed  using  ANOVA.  Pearson's  R  correlations  between  IOS 
measurements,  conventional  pulmonary  function  measurements,  and  questionnaire  based 
symptom  scores  will  be  obtained  and  the  impact  of  the  variables  listed  above  will  also  be 
evaluated. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  twelve  subjects  enrolled  in  the  past 
eight  months  (Asthma  (1),  COPD  (4),  and  no  lung  disease  (7).  The  information  obtained  in  this 
study  is  from  a  single  visit;  no  follow  up  is  required  unless  a  new  diagnosis  is  discovered.  Of  the 
arms  in  the  study  actively  enrolling,  no  new  diagnoses  have  been  found.  Patient  recruitment 
continues,  but  has  been  difficult  due  to  frequent  deployments  and  staff  and  technician  shortages. 


231 


Detail  Summary  Sheets 

Nutrition  Care  Division 


232 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206008  Status:  Ongoing 

Title:  Attenuation  of  Exertional  Muscle  Damage  with  a  Nutritional  Supplement 
Principal  Investigator:  Colleen  Cates-Gorang,  R.D.,  CDE 

Department:  Nutrition  Care  Facility:  MAMC 

Associate  Investigator(s):  LTC  Leslee  F.  Sanders,  MC;  Patricia  A.  Deuster,  PhD;  MAJ  Steven 
D.  Mahlen,  MS;  CPT  Eric  Grenier,  SP;  CPT  Michael  J.  Hartenstine,  MS 

Start  -  Completion:  Funding:  Periodic  Review: 

2/9/2006  -  Aug  2006  DCI  9/26/2006 

Study  Objective:  Determine  the  extent  to  which  ingestion  of  a  carbohydrate  (CHO) -electrolyte 
beverage  with  essential  amino  acids  (EAA)  to  include  glutamine,  by  soldiers  during  and  after 
strenuous  exercise  prevents  exertional  muscle  damage  (EMD)  as  compared  to  a  carbohydrate- 
electrolyte  beverage  alone.  Biochemical  analysis  will  include  measuring  plasma  markers  of 
damage  such  as  creatine  kinase  (CK)  and  interleukin-6  (IL-6),  blood  in  urine  and  subjective 
measurements  of  pain  in  a  group  of  soldiers  before,  after,  and  48  hours  after  a  strenuous  military 
training  event. 

Technical  Approach:  The  study  will  be  a  randomized,  double-blind,  crossover  design  utilizing 
Fort  Lewis  soldiers  as  the  study  population.  Subjects  will  be  divided  into  two  groups  of  a  minimum 
of  ten  per  group  and  assigned  to  one  of  two  treatment  conditions,  either  receiving  a  placebo 
beverage  or  the  treatment  beverage.  Both  beverages  will  be  manufactured  by  the  Gookinaid 
Company  per  the  following  specifications:  the  placebo  beverage  will  contain  45-60  grams  of 
carbohydrate  per  liter,  270  milligrams  of  sodium  and  400-500  milligrams  of  potassium  providing  a 
calorie  range  of  180-240  per  liter  (similar  to  a  commonly  available  sports  drink  such  as  Poweraid); 
the  treatment  beverage  will  consist  of  the  placebo  plus  5  grams  per  liter  of  essential  amino  acids 
and  3.5  grams  per  liter  of  glutamine  and  provide  215-275  calories  per  liter  (equivalent  to  adding  a 
glutamine  powder  such  as  ProLab  Glutamine®  to  a  sports  beverage  or  utilizing  a  sports  beverage 
such  as  Growling  Dog  Replacement  Drink®,  both  widely  available  for  purchase). 

The  subjects  will  participate  in  a  7  V2  mile  road  march  carrying  a  backpack  weighted  to  30%  of 
his/her  body  weight  (up  to  a  maximum  of  83  pounds)  -  or  an  event  similar  in  difficulty  level.  A 
minimum  of  1  liter  of  beverage  will  be  ingested  each  hour  during  the  event  and  an  additional  1 
liter  of  beverage  consumed  within  two  hours  afterwards.  After  a  7-14  day  washout  period,  the 
event  will  be  repeated,  with  the  subjects  consuming  the  alternate  beverage;  each  subject  is  acting 
as  his/her  own  control  to  determine  difference  in  treatment  effect.  Within  subject  and  between 
treatment  group  comparisons  will  be  performed  using  AN OVA.  Performance,  metabolic  and 
muscle  damage  response  data  will  be  evaluated  with  repeated-measures  ANOVAs  and  t-tests. 
Dietary  intake  of  specific  nutrients  will  be  estimated  for  each  subject  using  the  4-day  food  record, 
(previously  validated  and  utilized  at  the  University  of  Washington)  and  analyzed  with  software 
from  the  University  of  Minnesota  -  Nutrient  Data  System  for  Research  (or  similar  software). 

Progress:  Thus  far,  33  Soldiers  have  completed  both  phases  of  study  since  protocol  approval. 

Data  analyses  are  on-going,  with  aliquots  currently  stored  for  approved  future  laboratory  analyses, 
as  funding  allows.  Statistical  analyses  are  pending. 


233 


Detail  Summary  Sheets 

Department  of  Nursing 


234 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206093  Status:  Ongoing 

Title:  Effects  on  Aspirated  Volume,  Patency,  and  Tracheal  Mucosa  using  High  Intermittent 

Negative  Pressure  versus  Low  Continuous  Negative  Pressure  for  Subglottic  Secretion  Aspiration 

Principal  Investigator:  Charlotte  L.  DePew,  RN,  MSN 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  LTC  Cynthia  L.  Clagett,  MC;  MAJ  Steven  P.  Bennett,  MC;  Mary  S. 

McCarthy,  RN,  PhD;  Nora  A.  Regan,  CRT;  MAJ  William  F.  Kelly,  MC;  MAJ  Alexander  S.  Niven, 

MC;  MAJ  Jeffrey  B.  Musser,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/1/2006  -  Dec  2006  DCI  N/A 

Study  Objective:  Objectives:  To  determine  the  effect  on  aspirated  secretion  volume  using  high 
intermittent  versus  low  continuous  subglottic  secretion  aspiration  with  the  HiLo  Evac 
endotracheal  tube.  To  determine  the  effect  on  line  patency  using  high  intermittent  versus  low 
continuous  subglottic  secretion  aspiration  with  the  HiLo  Evac  endotracheal  tube.  To  describe  the 
effect  on  tracheal  mucosa  using  photographic  images  obtained  endoscopically  when  evaluating 
high  intermittent  versus  low  continuous  subglottic  secretion  aspiration  with  the  HiLo  Evac 
endotracheal  tube. 

Technical  Approach:  This  study  will  use  a  prospective,  quasi-experimental  design  to  answer  the 
important  questions  about  maintaining  line  patency,  effectively  removing  secretions,  and 
minimizing  mucosal  trauma  from  applied  negative  pressure.  Sixty  subjects  will  be  required  with 
30  per  group  receiving  either  low  continuous  suction  or  high  intermittent  suction.  Method  of 
suction  will  alternate  each  month  for  6  months.  Patients  will  be  included  if  they  require 
mechanical  ventilation  for  longer  than  3  days.  At  that  point  consented  patients  will  receive  a 
baseline  video-assisted  tracheoscopy  at  the  time  of  their  routine  subglottic  suctioning  intervention. 
Mucosal  trauma  will  be  graded  according  to  the  Modified  Mathias-Wedley  Tool.  From  that  point 
on,  patients  will  receive  a  once  daily  video-assisted  tracheoscopy  every  one  to  three  days  with 
grading  of  any  mucosal  injury.  A  secretion  specimen  taken  during  the  tracheoscopy  from  above  the 
cuff  will  be  submitted  for  microbiologic  examination.  Patency  and  secretion  volume  aspirated  will 
also  be  recorded  daily.  Data  will  be  analyzed  by  Student's  t  test  for  group  comparisons  and 
ANOVA/ANCOVA  for  individual  /  group  comparisons  over  time.  The  results  will  be  used  to  finalize 
the  evidence-based  practice  protocol  for  prevention  of  VAP  in  the  MAMC  ICU. 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled  during  FY06.  Study 
staff  have  asked  Department  of  Anesthesia  to  add  the  HiLo  Evac  ETT  to  their  emergency 
intubation  bags.  Several  opportunities  for  enrollment  were  missed  since  Anesthesia  often  uses 
their  own  ETT  for  emergent  intubation. 


235 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203030  Status:  Completed 

Title:  Junior  Army  Nurse  Corps  Officers'  Perceptions,  Experiences  and  Expectations  of  Head 

Nurse  Leadership 

Principal  Investigator:  MAJ  Jean  M.  Jones,  AN 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Lori  A.  Loan,  RNC,  Ph.D.;  CPT  Linda  L.  Blackman,  AN;  COL  (Ret) 

Eileen  A.  Hemman,  PhD 

Start  -  Completion:  Funding:  Periodic  Review: 

5/16/2003  -  Oct  2003  DCI  1/12/2006 

Study  Objective:  Describe  Junior  Army  Nurse  Corps  Officers'  perceptions,  experiences,  and 
expectations  of  head  nurse  leadership  at  Madigan  Army  Medical  Center. 

Technical  Approach:  Selected  Participants  will  be  will  be  mailed  information  on  the  research 
study  approximately  3  weeks  prior  to  the  anticipated  start  date  of  the  study  through  MAMC 
distribution.  Those  volunteering  to  participate  will  be  scheduled  for  attendance  at  focus  group 
sessions  through  telephone  calls  made  by  non  military  administrative  personnel  in  the  Nursing 
Research  Office  10  to  14  days  prior  to  the  session.  Each  focus  group  session  will  last  up  to  120 
minutes  to  include  administrative  time  for  informed  consent,  preliminary  instructions,  and 
answering  participant  questions.  All  focus  group  interviews  will  take  place  in  a  site  in  the  hospital. 
Locus  groups  will  begin  by  the  moderator  introducing  the  agenda  and  sharing  ground  rules  for 
participation.  Comments  generated  from  the  focus  group  discussions  will  be  recorded  using  an 
audio  tape  recorder  and  one  other  research  team  member  (the  PI,  Cl,  SC  and/or  RA)  will  be  a  non¬ 
participant  observer.  The  facilitator  will  guide  and  focus  the  group  discussion  and  interaction, 
while  the  observer  will  record  the  discussion,  note  participants'  interaction  patterns  and  non¬ 
verbal  responses  as  additional  data.  Additional  field  notes  will  be  written  when  the  facilitator  and 
the  non-participant  observer  debrief  after  each  focus  group. 

Progress:  The  final  Head  nurse  (HN)  focus  group  was  held  and  data  were  analyzed  using 
Husserlian  descriptive  phenomenology,  predominately  Collazzi's  approach.  HN  leadership 
characteristics  that  positively  impact  Junior  Officer  (JO)  retention  included:  (1)  HNs  that  have  a 
desire  to  serve  in  the  HN  Role,  are  clinically  competent  and  administratively  effective,  counsel  per 
standards  and  provide  career  development  guidance,  provided  fair  and  equitable  schedules  for 
civilian  and  military  staff,  use  the  ANC  Lifecycle  as  a  tool  to  guide  careers  (However  the  Lifecycle 
should  be  based  on  today's  optempo,  include  more  TO&E  positions  and  a  clinical  track.),  mentor 
JOs  early,  and  provide  recognition  based  on  performance  and  achievement,  not  rank;  and  (2) 

Senior  leaders  that  mentor  and  develop  HNs,  provide  realistic  HN  preceptorships,  select  HNs 
based  on  recommendations  and  resumes,  and  only  selecting  the  best  of  the  best. 

The  study  identified  significant  differences  between  HN  and  Junior  ANC  Officer 
perceptions  that  also  may  negatively  impact  retention  including:  (1)  Counseling-HNs  perceived 
that  JOs  wanted  lengthy  counseling.  JOs  wanted  HNs  to  counsel  quarterly  and  provide  career 
guidance;  (2)  Mentoring-HNs  attempted  to  mentor  JOs  by  giving  them  jobs  like  Schedule, 
Performance  or  Education  Coordinator  to  help  develop  leadership  skills.  JOs  said  HNs  didn't  know 
how  to  properly  mentor  and  they  did  not  view  HN  delegated  jobs  as  career  enhancing;  (3) 
Recognition-HNs  perceived  that  JOs  want  more  public  recognition.  JOs  wanted  acknowledgement 
based  on  the  achievement,  not  rank;  and  (4)  Scheduling-HNs  perceived  that  JOs  didn't  want  to 
work  night  or  weekend  shifts  or  more  than  forty  hours  per  week.  JOs  said  their  concern  was  the 
disparity  between  civilian  staffs  empowerment  to  get  desired  schedules  and  military  nurses'  lack 
of  a  voice  when  scheduling  issues  arose. 


236 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205117 

Status:  Ongoing 

Title:  A  Qualitative  Descriptive  Study  that  Identifies  Essential  Competencies  and  Leadership 
Characteristics  of  Army  Adult  Medical-Surgical  Critical  Care  Head  Nurses  (dissertation) 

Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing 

Facility:  MAMC 

Associate  Investigator(s):  COL  Roy  A.  Harris,  AN 

Start  -  Completion:  Funding: 

7/29/2005  -  May  2006  DCI 

Periodic  Review: 

7/10/2006 

Study  Objective:  The  purpose  of  this  study  is  to  identify  and  describe  competencies  and 
leadership  characteristics  of  Army  Adult  Medical- Surgical  Critical  Care  Head  Nurses.  The 
research  questions  are:  (1)  what  are  the  essential  competencies  and  leadership  characteristics 
identified  by  Army  Critical  Care  Head  Nurses  themselves,  (2)  what  are  the  essential  competencies 
and  leadership  characteristics  of  Army  Critical  Care  Head  Nurses  identified  by  Army  critical  care 
staff  nurses,  (3)  what  are  the  essential  competencies  and  leadership  characteristics  of  Army 
Critical  Care  Head  Nurses  identified  by  Army  Chief  Nurses,  and  (4)  what  common  essential 
competencies  and  leadership  characteristics  of  Army  Critical  Care  Head  Nurses  do  these  three 
levels  of  professional  nursing  identify? 

Technical  Approach:  This  is  a  qualitative,  descriptive  study  semi- structured  interviews  that 
include  both  closed-ended  and  open-ended  questions  as  the  primary  means  of  data  collection.  Five 
Army  Nurse  Corps  nurses  will  be  asked  to  participate  at  MAMC;  the  Chief  Nurse,  one  Critical 
Care  Head  Nurse,  and  three  Critical  Care  staff  nurses.  Total  study  subjects  from  all  sites  will  be 
35;  5  nurses  each  from  Walter  Reed  Army  Medical  Center,  Landstuhl  Regional  Medical  Center, 
Dwight  David  Eisenhower  Army  Medical  Center,  Tripler  Army  Medical  Center,  Brooke  Army 
Medical  Center,  William  Beaumont  Army  Medical  Center,  and  Madigan  Army  Medical  Center. 

The  associate  investigator  will  conduct  the  interviews  in  all  seven  medical  centers  and  at  all 
echelons.  Documented  informed  consent  will  be  obtained  to  allow  subjects  to  decline  enrollment. 
The  consent  process  will  not  be  conducted  by  the  associate  investigator  who  will  be  conducting  the 
interviews. 

Demographic  data  will  be  collected  which  will  serve  as  a  descriptive  framework  during  the 
analysis  phase  of  the  study.  Frequencies  and  measures  of  central  tendency  will  be  utilized  to 
analyze  the  respondent's  demographic  data.  Other  analyses  will  be  conducted  using  descriptive 
qualitative  methodology.  Qualitative  analysis  of  the  data  will  be  completed  with  a  focus  on  a 
comprehensive  description  of  essential  competencies  and  leadership  characteristics  of  Army 
Critical  Care  Head  Nurses  as  perceived  by  the  three  echelons  of  respondents.  To  ensure  that 
ongoing  analysis  occurs  throughout  the  study,  the  modality  of  constant  comparative  analysis  will 
be  utilized.  The  data  will  be  organized  by  transcribing  the  audiotapes  of  the  interviews  into  the 
Microsoft  word  processing  program.  The  transcriptions  will  be  entered  into  the  computer  program, 
NVivo  to  facilitate  the  coding  process.  Information  gleaned  from  this  study  will  be  de-identified 
and  aggregated  and  used  as  part  of  the  associate  investigator's  dissertation  requirement  at  George 
Mason  University.  Findings  will  also  be  offered  to  the  Army  Nurse  Corps,  presented  at  nursing 
conferences  and  published  in  a  national  nursing  journal. 

Progress:  Data  collection  is  completed  with  a  total  of  30  interviews  from  6  different  Army  Medical 
Centers.  IRB  approval  at  Tripler  Army  Medical  Center  took  much  longer  than  other  IRBs  and 
therefore  the  timeline  became  too  long  to  complete  research  in  a  timely  manner  for  completion  of 
dissertation  this  Fall.  After  discussion  with  Dissertation  Chair  and  committee,  it  was  decided  that 
30  interviews  from  the  remaining  medical  centers  was  sufficient  to  achieve  saturation.  All  30 


237 


interviews  are  completed  and  transcribed.  All  interviews  have  been  sent  to  the  interviewees  for 
review  and  comment  (per  proposal)  and  20  have  been  returned.  The  transcripts,  tapes  and  notes 
are  all  secured  in  accordance  with  the  proposal.  There  have  been  no  complaints  from  any  of  the 
interviewees  either  during  the  interview  process  or  afterwards.  Many  expressed  tremendous 
enthusiasm  in  participation  and  were  very  interested  in  findings.  This  study  is  entering  data 
analysis  that  will  utilize  the  NVivo  7  program.  The  three  basic  skill  sets  of  technical,  human  and 
conceptual  (Katz)  become  the  foci  of  sorting  responses  (per  proposal).  Data  anlaysis  will  look  at 
responses  to  each  question  and  a  comparison  within  each  echelon  of  leadership  as  well  as  the 
contrasts  between  the  echelons  of  nursing  leadership.  Anticipated  conclusion  of  study  is  Fall  2006. 


238 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202066  Status:  Ongoing 

Title:  Caring  Interventions  for  Couples  Who  Have  Miscarried 
Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Kristen  M.  Swanson,  RN,  Ph.D.,  FAAN;  Mark  A  Biernbaum,  Ph.D.; 
Kathryn  Barnard,  RN,  Ph.D.,  FAAN;  Martha  J.  Lentz,  BSN,  MN,  Ph.D.;  Margaret  M. 
Heitkemper,  Ph.D. 

Start  -  Completion:  Funding:  Periodic  Review: 

5/16/2002  -  Oct  2004  NIH  via  MIPR  5/9/2006 

Study  Objective:  The  purpose  of  this  randomized  study  is  to  compare  the  effects  of  nurse  caring 
(3  nurse  counseling  sessions),  self-caring  (3  home-delivered  video  tapes  and  journals),  combined 
caring  (1  nurse  counseling  session  plus  3  videotapes  and  journals)  and  no  intervention  (control)  on 
the  emotional  healing,  integration  of  loss  and  couple  well-being  of  women  and  their  partners 
(husbands  or  male  mates)  in  the  first  year  after  miscarrying. 

Technical  Approach:  340  couples(or  680  individuals)  will  be  recruited  to  participate  in  a  4 
group,  pre-test,  post-test  randomized  study  of  a  counseling  intervention  meant  to  reduce  distress 
and  enhance  couple  well-being  following  miscarriage.  Upon  recruitment,  individuals  will  be 
informed  that  they  may  be  randomized  into  a  group  that  will  not  receive  any  treatment.  Four 
groups  will  be  followed  for  1  year.  All  participants  will  fill  out  4  questionnaire  packets  throughout 
the  study  period.  The  first  will  be  mailed  after  the  couple  initially  agrees  to  participate.  The  other 
questionnaire  booklets  will  be  sent  at  6  weeks,  16  weeks  and  1  year  after  their  initial  enrollment 
in  the  study. 

Progress:  The  study  reached  its  targeted  enrollment  of  340  couples  during  FY05.  Thus  far,  183 
couples  have  completed  the  entire  study  protocol.  Steady  progress  is  being  made  towards 
achievement  of  study  aims.  Preliminary  data  analyses  have  begun.  The  intervention  nurses  are 
conducting  in-home  counseling  sessions  with  couples  and  meet  regularly  for  supervision.  Study 
data  are  being  double  entered  into  an  SPSS  secure  database.  Syntax  files  for  data  analysis  have 
been  developed.  Data  Safety  and  Monitoring  Board  meetings  occur  at  the  University  of 
Washington  as  mandated  by  the  funding  source.  Recruitment  is  closed  at  all  sites:  University  of 
Washington  Medical  Center,  Madigan  Army  Medical  Center,  Group  Health  Cooperative,  and 
Evergreen  Hospital  Medical  Center. 

During  FY06,  recruitment  was  reported  as  completed  and  all  participants  completed  the 
interventions.  Data  cleaning  and  data  analysis  continues 


239 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205037  Status:  Ongoing 

Title:  Determining  the  Effectiveness  of  a  Stroke  Prevention  Program 
Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  LTC  Mona  0.  Bingham,  AN;  LTC  Jon  C.  Allison,  MC;  Nancy  A. 

Cox,  RN,  BSN;  Samuel  C.  Sorbello,  RN 

Start  -  Completion:  Funding:  Periodic  Review: 

2/3/2005  -  Jan  2011  DCI  1/20/2006 

Study  Objective:  To  determine  the  effectiveness  of  an  intensive  one-on-one  case  management 
program  designed  to  control  identified  risk  factors  for  stroke  and  reduce  the  incidence  of  stroke  in 
target  population. 

Technical  Approach:  This  longitudinal  study  will  use  a  randomized,  two  group  repeated 
measures  design  to  compare  a  nurse  case  management  stroke  prevention  program  to  standard 
care  provided  by  primary  care  services  in  order  to  determine  the  effectiveness  of  an  intensive  1:1 
case  management  intervention.  After  one  year  there  may  be  a  cross-over  group  of  those  control 
subjects  who  wish  to  enter  the  case  management  intervention  program.  The  study's  primary 
outcomes  are  blood  pressure,  LDL,  HgAlc,  and  BMI  (as  calculated  from  measures  of  height  and 
weight).  Secondary  outcome  measures  include  including  incidence  of  vascular  events, 
hospitalizations,  emergency  room  visits,  progression  of  carotid  artery  disease,  control  of  atrial 
fibrillation,  tobacco  cessation  and  decreased  tobacco  use,  and  exercise  level.  Quality  of  life,  mental 
wellness,  and  overall  health  will  also  be  measured  through  approved  survey  instruments  available 
on  the  MAMC  web  system. 

Medical  information  from  case  management  visits,  medical  records,  hospital  information,  and 
health  instruments  will  be  used  to  compile  data  for  this  study.  Chi-square,  t-tests,  ANOVA  with 
repeated  measures,  and  Mann- Whitney  U  tests  will  be  used  to  compare  group  outcomes.  The 
actual  1:1  case  management  intervention  will  last  one  year.  At  the  end  of  one  year,  each  patient 
will  be  re-evaluated  to  determine  if  case  management  services  are  still  needed.  At  this  time, 
control  patients  will  be  asked  if  they  would  like  to  receive  case  management  services  until  capacity 
is  reached  for  case  management  load.  Results  will  be  analyzed  at  6  months,  1  year,  and  for  5  years 
there  after  for  study  subjects. 

Progress:  This  protocol  remains  ongoing.  A11  baseline  and  six  month  data  collection  is  complete. 
One  year  data  has  been  collected  for  over  half  of  the  participants. 


240 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204084  Status:  Ongoing 

Title:  Impact  of  Inpatient  Physician  Order  Entry  on  Medication  Administration  and  Dispensing 
Error  Rates  in  the  Neonatal  Intensive  and  Intermediate  Care  Units 

Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  LTC  Donna  C.  Whitney,  MC;  James  A.  Taylor,  M.D.;  Susan 
Blackburn,  Ph.D.,  RNC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/14/2004  -  Jun  2005  DCI  5/20/2006 

Study  Objective:  The  proposed  study  will  be  conducted  in  two  phases.  Phase  One  is  designed  to 
pilot  test  an  observational  methodology  called  Line  Operator  Safety  Audit  (LOSA)  and  modify 
LOSA  for  use  with  medication  error  detection  in  the  NICU/ICN  and  inpatient  pharmacy.  Phase 
One  will  also  include  refinement  of  data  collection  instruments  and  techniques.  Once  the  optimal 
observation  techniques  and  data  collection  instruments  are  determined,  Phase  Two  will  begin.  In 
this  phase  the  number  and  types  of  observed  medication  administration  and  dispensing  errors  will 
be  compared  before  and  after  inpatient  physician  order  entry  is  initiated  in  the  NICU/ICN  at 
Madigan  Army  Medical  Center. 

Technical  Approach:  This  study  will  examine  medication  errors  before  and  after  the  initiation  of 
inpatient  physician  order  entry  (IPOE)  in  the  Neonatal  Intensive  Care  Unit  (NICU)  or 
Intermediate  Care  Nursery  (ICN),  and  point  out  what  types  of  errors  are  common  in  this  patient 
population.  Approximately  25  health  care  personnel  dispensing  (pharmacy  personnel)  or 
administering  (nursing  personnel)  medications  for  NICU  or  ICN  patients  will  be  watched  until 
approximately  750  opportunities-for-error  have  been  observed.  The  study  will  use  a  pretest- 
posttest  design  and  appropriate  statistical  techniques  (t-test,  Mann  Whitney  U  or  chi-square)  to 
compare  medication  administration  and  dispensing  error  rates  from  two  data  collection  periods-  1- 
month  before  NICU/ICN  IPOE  begins  and  4  months  after  NICU/ICN  IPOE  is  initiated. 

Information  from  the  study  will  be  used  to  develop  practical  error-prevention  strategies. 

Progress:  All  medication  variance  observations  have  been  completed.  In  total,  there  were  253 
baseline  and  266  post  physician  order  entry  observations.  Preliminary  analysis  suggests  a 
statistically  significant  decrease  in  the  overall  medication  administration  variance.  The  protocol 
remains  ongoing  to  complete  data  analysis  already  in  progress. 


241 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204031 

Status:  Ongoing 

Title:  Military  Nursing  Outcomes  Database:  Analysis  &  Expansion  (MilNOD  IV) 

Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing 

Facility:  MAMC 

Associate  Investigator(s):  ETC  Patricia  A.  Patrician,  AN;  COL  Laura  R.  Brosch,  AN 

Start  -  Completion:  Funding: 

4/8/2004  -  Aug  2005  Triservice  Nursing  Research  Program  via  The 

Geneva  Foundation 

Periodic  Review: 

12/13/2006 

Study  Objective:  This  is  the  fourth  study  (MilNOD  IV)  in  a  program  of  research  examining  nurse 
staffing  and  patient  outcomes.  This  particular  study  will  shift  from  database  development  to 
examining  aspects  of  structure,  process,  &  outcome. 


Technical  Approach:  Data  deemed  valid  and  reliable  from  the  study,  "Establishing  a  Military 
Nursing  Outcome  Database"  (Brosch,  2002),  will  undergo  secondary  analyses  to  examine 
relationships  between  nursing  structure  indicators,  and  patient  and  nurse  outcome  indicators.  The 
research  team  will  specify  a  series  of  regression  models,  examining  each  outcome  variable 
separately.  For  survey  subscales  on  the  Nursing  Work  Index-Revised  and  the  Patient  Satisfaction 
Survey,  correlations  will  be  performed  to  examine  associations  among  independent  variables  and 
between  independent  and  dependent  variables.  Simple  Pearson's  correlations  will  indicate 
whether  a  relationship  exists  between  nurse  and  patient  satisfaction. 

Progress:  Subjects  include  patients  who  were  surveyed  for  the  patient  satisfaction  indicator  and 
nursing  personnel  surveyed  for  their  education/experience/certification  activities,  their  job 
satisfaction,  and  the  attributes  of  their  work  environment.  Retrospective  data  are  collected  from 
patients  participating  in  the  pressure  ulcer  prevalence  survey  as  well.  Each  type  of  survey  was 
conducted  at  MAMC  once  in  FY'06,  except  the  pressure  ulcer  prevalence  data  are  collected 
biannually.  All  13  participating  MTFs  submitted  survey  data  along  with  shift-level  nurse  staffing 
data  and  patient  outcome  data  to  a  project- specific  electronic  database  during  FY  '06.  Data 
collection  has  now  been  discontinued  and  a  data  analysis  plan  is  being  formulated. 


242 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201104 

Status:  Ongoing 

Title:  Newborn  Infant  Speech  Perception 

Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Randall  C.  Zernzach,  MC,  USAF; 
Christine  Moon,  PhD 

Tricia  K.  Grannis,  R.N.; 

Start  -  Completion:  Funding: 

11/1/0168  -  May  2003  UW 

Periodic  Review: 

6/20/2006 

Study  Objective:  Characterize  the  effect  of  experience  on  typically  developing  newborn  infants' 
perception  of  speech  and  language. 

Technical  Approach:  The  current  proposal  for  research  is  for  a  2-year  study  of  newborn  infant 
discrimination  of  familiar  and  unfamiliar  speech  sounds.  Three  experiments  will  comprise  the 
study.  The  first  will  test  newborns'  ability  to  discriminate  mother's  voice  from  a  stranger  voice 
when  the  speech  samples  are  brief.  The  second  experiment  will  examine  whether  infants  respond 
preferentially  to  their  mother's  native  language  when  the  samples  are  brief.  In  the  third 
experiment,  infants  will  be  tested  for  their  ability  to  discriminate  brief  vowel  sounds  from  among 
well-  and  poorly-formed  exemplars  in  English.  Each  of  the  three  experiments  will  require  data 
from  80  participants  for  a  total  of  240  infants.  Because  the  attrition  rate  for  completion  of  the  10- 
minute  session  is  likely  to  be  about  35%,  it  is  expected  that  approximately  360  infants  will  be 
recruited  and  that  120  will  not  complete  the  experiment. 

Prospective  participants  will  be  1-5  days  old  and  will  be  identified  from  hospital  records.  Eligibility 
will  be  based  upon  criteria  that  indicate  typical,  uncomplicated  newborn  development.  Parents  will 
be  contacted  in  their  hospital  rooms  by  the  experimenters  who  will  present  the  study  and  obtain 
signed,  informed  consent.  Infants  will  be  transported  to  a  quiet  area  near  the  newborn  unit  for  a 
20-minute  session.  A  pacifier  that  is  connected  to  a  pressure  transducer  will  be  placed  in  the 
infant's  mouth.  If  the  pacifier  is  accepted,  headphones  will  be  placed  over  the  infant's  ears.  After  a 
1 -minute  baseline  period  to  measure  sucking  pressure,  computer-controlled  sounds  at 
conversational  levels  of  intensity  will  be  presented  for  9  minutes,  contingent  upon  infant  sucking 
pressure.  Frequency  of  sucks  during  particular  stimuli  will  be  the  dependent  measure.  Data 
analysis  will  be  based  upon  a  comparison  of  sucking  frequency  during  different  sounds.  Results  of 
the  experiments  will  be  presented  at  professional  conferences  and  submitted  as  articles  for 
publication  in  professional  journals. 

Progress:  Due  to  an  unexpected  loss  of  research  funding,  the  pace  of  data  collection  slowed  during 
the  past  year;  however,  analysis  of  data  in  the  database  continued.  The  analyses  confirm  newborn 
recognition  and  preference  for  mother's  voice,  and  they  extend  past  results  by  demonstrating  that 
pitch  of  the  voice  (fundamental  frequency  and/or  spectral  slope)  is  an  important  cue  to  voice 
recognition  by  newborn  infants.  This  is  consistent  with  the  idea  that  newborns  are  relying  on 
prenatal  voice  cues  for  postnatal  perception.  Pending  replication  of  the  pitch  results,  a  paper  on 
the  topic  will  be  submitted  to  an  infant  development  journal. 


243 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  202075  Status:  Ongoing 

Title:  Secondary  Analysis  of  NICU  Modified  Care  Environment  Projects 
Principal  Investigator:  Lori  A.  Loan,  RNC,  Ph.D. 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Karen  A.  Thomas,  Ph.D.,  RN;  Susan  T.  Blackburn,  Ph.D.,  RN, 
LAAN;  Shu-Yuann  Wang,  MS,  RN;  Ms  Sara  Brown,  RN;  Shao-Yu  Tsai 

Start  -  Completion:  Funding:  Periodic  Review: 

1/7/0168  -  May  2005  DCI  5/9/2006 

Study  Objective:  Secondary  analysis  of  data  collected  in  previously  approved  projects  is 
proposed.  Prior  human  use  approvals  were  (1)  The  Effects  of  a  Modified  Care  Environment  on  the 
Growth  and  Development  of  High  Risk  Infants,  P.I.  ETC  Michelle  T.  Renaud,  approved  4 
September  1992,  and  (2)  a  continuation  and  extension,  Neonatal  Outcomes  in  a  Modified  NICU 
Environment,  P.I.  ETC  Michelle  T.  Renaud,  approved  13  July  1993.  Additionally  these  projects 
were  approved  by  the  University  Of  Washington  Human  Subjects  Division.  Both  projects  included 
Karen  Thomas  and  Susan  Blackburn,  UW  faculty,  as  Co-Principal  Investigators. 

The  original  projects  involved  comparison  of  two  neonatal  intensive  care  unit  environments  that 
included  reduced  light  and  sound  levels.  Infants  randomized  to  the  control  group  remained  in  the 
standard  nursery.  Both  groups  of  infants  received  standard  medical  and  nursing  care  in  all 
respects,  except  for  the  nursery  environment.  Data  collect  during  the  study  included  infant  health 
status,  parent  demographic  information,  duration  of  hospitalization,  environmental  sound  and 
light  levels,  neurologic  and  behavioral  assessment  and  infant  sleep-wake  states.  Infant  sleep-wake 
stated  was  measured  by  3-4  hour  video  recordings  performed  at  34  weeks  gestational  age  and 
again  at  time  of  discharge.  Video  recordings  were  performed  while  infants  were  in  incubators  or  in 
open  crib  and  display  the  infant's  body  and  face. 

For  the  second  analysis,  investigators  are  requesting  permission  for  activities:  (1)  Photo  copies  to 
be  made  of  existing  video  coding  sheets,  (2)  Access  to  video  tapes  for  recording  purposes,  (3)  Use  of 
existing  data  base  by  the  three  graduates  named  above. 

Technical  Approach:  The  proposed  research  is  a  secondary  analysis  of  data  from  a  previously 
approved  project  that  was  conducted  at  MAMC  in  conjunction  with  nurse  researchers  from  the 
University  of  Washington  Department  of  Family  and  Child  Nursing.  Permission  is  requested  for 
use  of  data  by  a  total  of  three  nursing  graduate  students.  Computer  files  containing  the  data  from 
the  original  project,  excluding  identifiers,  is  currently  in  the  possession  of  Karen  Thomas. 
Permission  is  requested  to  photocopy  the  video  coding  sheets,  currently  held  at  MAMC  for  use  by 
investigators  at  the  University  of  Washington.  Permission  is  also  requested  for  temporary  use  of 
the  videotapes  at  the  U.W.  The  video  coding  sheets  will  be  used  to  enter  the  raw  data  into  a 
computer  file.  Videos  will  be  used  to  determine  reliability  of  original  coding  and  to  code  additional 
infant  behaviors  and  care  giving  activities. 

Progress:  One  doctoral  student,  Shu-Yuann  Wang,  continues  to  analyze  data  from  the  parent 
project.  This  data  is  anonymized;  investigators  at  the  University  of  Washington  do  not  have  access 
to  the  original  code  list,  and  the  data  set  does  not  include  any  information  which  would  allow 
identification  of  subjects.  Ms.  Wang  will  complete  her  dissertation  by  June  2006.  Two  graduates, 
Shao-Yu  Tsai  and  Sara  Brown,  whose  Masters  theses  were  based  on  the  secondary  analysis,  along 
with  Dr.  Karen  Thomas,  have  submitted  a  journal  manuscript  based  on  study  findings.  Ms.  Tsai's 
poster  presentation  at  the  Western  Institute  for  Nursing  conference  (An  Exploratory  Analysis: 


244 


Environmental  Modifications  on  the  Sleep-Wake  State  in  Preterm  Infants  -  Portland,  OR,  2004) 
received  an  award  for  doctoral  student  research. 


245 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206108  Status:  Ongoing 

Title:  Army  Nurse  Corps  Officers'  Deployment  Experiences  and  Reintegration 

Principal  Investigator:  COL  Laurie  A.  McNabb,  AN 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Lori  A.  Loan,  RNC,  Ph.D.;  LTC  Denise  Hopkins-Chadwick,  AN; 

Mary  S.  McCarthy,  RN,  PhD 

Start  -  Completion:  Funding:  Periodic  Review: 

7/10/2006  -  Jun  2007  DCI  N/A 

Study  Objective:  To  explore  the  many  factors  that  impact  nurses'  ability  to  perform  their  jobs 
during  all  phases  of  a  deployment;  prior  to  the  deployment,  during  the  deployment,  and  during  the 
post-deployment  phase.  Outcomes  of  this  study  will  serve  as  the  basis  for  the  development  of  the 
best  strategies  to  support  nurses  prior  to  and  following  a  deployment  in  order  to  facilitate  the 
smoothest  transition,  between  workplaces. 

Technical  Approach:  Prospective  Data  Collection  Procedures:  Army  Nurse  Corps  Officers  will  be 
recruited  based  on  the  inclusion  criteria  and  availability.  Nurses  interested  in  participating  in  the 
study  will  be  contacted  by  phone  or  email.  During  this  initial  call,  one  of  the  study  investigators 
will  discuss  a  variety  of  issues  with  each  participant  such  as  the  study  purpose,  what  will  be 
needed  from  them  as  participants,  who  will  be  at  the  group  or  interview,  and  other  specifics  of  the 
focus  group  sessions.  They  will  be  given  information  about  the  study  and  their  questions  will  be 
answered.  Those  volunteering  to  participate  will  be  scheduled  for  attendance  at  focus  group 
sessions  or  interviews  through  telephone  calls  or  personal  interactions  carried  out  7  to  14  days 
prior  to  the  session.  To  increase  attendance,  participants  will  again  be  contacted  telephonically  by 
a  research  team  member  24  hours  prior  to  the  date  and  time  of  the  session  (Goldstein  & 

McDonald,  1987;  Krueger,  1988;  Stewart  &  Shamdasani,  1990).  Participants  will  also  be  given  a 
demographic  data  collection  sheet  and  asked  to  complete  it  and  bring  it  to  the  focus  group  meeting. 
These  sheets  will  be  collected  from  participants  after  consenting  is  complete.  If  participants  fail  to 
bring  the  sheet,  they  will  be  asked  to  supply  demographic  information  at  the  time  of  the  focus 
group  session. 

Progress:  This  protocol  remains  open  to  enrollment.  Twelve  subjects  have  participated  in  focus 
groups  at  MAMC  so  far. 


246 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206107  Status:  Ongoing 

Title:  Menstruation  During  Deployment:  Women's  Attitudes  Towards  Menstrual  Suppression 
Principal  Investigator:  LTC  Lori  L.  Trego,  AN 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Lori  A.  Loan,  RNC,  Ph.D.;  LTC  Denise  Hopkins-Chadwick,  AN;  1LT 
Sandra  L.  Gordy,  AN 

Start  -  Completion:  Funding:  Periodic  Review: 

7/10/2006  -  Aug  2007  DCI  N/A 

Study  Objective:  Objective  is  to  perform  instrument  development  and  testing  of  a  military- 
specific  measure  of  the  experience  of  menstruation  and  associated  attitudes  towards  menstrual 
suppression  in  a  deployed  environment.  Specific  Aims  are  to  (1)  establish  the  reliability  (internal 
consistency)  of  an  instrument  that  measures  military  women's  experiences  of  menstruation  and 
attitudes  towards  menstrual  suppression  and  (2)  establish  the  validity  (content,  face,  construct, 
convergent,  discriminant)  of  an  instrument  that  measures  military  women's  experiences  of 
menstruation  and  attitudes  towards  menstrual  suppression. 

Technical  Approach:  Data  collection  will  be  the  administration  of  a  paper  and  pencil  survey 
consisting  of  the  Military  Women's  Attitudes  Towards  Menstrual  Suppression,  the  Attitudes 
Towards  Menstrual  Suppression  Scale  (ATMS),  the  Menstrual  Attitudes  Questionnaire  (MAQ), 
and  a  Deployed  Menstrual  Health  Practice  Questionnaire  (DMHPQ).  Targeted  sample  size  per 
power  analysis  is  300-500  participants,  as  required  for  factor  analysis.  Psychometric  testing  with 
this  sample  size  allows  for  tests  of  internal  consistency  and  item  evaluation  in  the  assessment  of 
reliability  as  well  as  exploratory  factor  analysis  for  construct  validation.  Several  methods  of 
construct  validity  have  been  chosen  for  this  study:  content  validity,  face  validity,  construct 
validity,  and  convergent  and  discriminant  construct  validity.  The  sample  will  therefore  complete  a 
questionnaire  that  consists  of  the  MW  ATMS,  as  well  as  two  other  valid  instruments  that  will  be 
used  to  test  convergent  and  discriminant  validity:  the  Menstrual  Attitude  Questionnaire  (MAQ) 
and  the  Attitudes  Towards  Menstrual  Suppression  scale  (ATMS). 


Progress:  Twenty-three  Soldiers  have  participated  in  this  study.  There  have  been  no  adverse 
occurrences  and  no  preliminary  findings  are  available.  Enrollment  will  continue  during  FY07. 


247 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206002  Status:  Completed 

Title:  Military  Women's  Thoughts  about  Menstruation  and  Menstrual  Suppression  During 

Deployment 

Principal  Investigator:  LTC  Lori  L.  Trego,  AN 

Department:  Nursing  Facility:  MAMC 

Associate  Investigator(s):  Lori  A.  Loan,  RNC,  Ph.D. 

Start  -  Completion:  Funding:  Periodic  Review: 

10/14/2005  -  Oct  2006  DCI  N/A 

Study  Objective:  This  study  will  be  conducted  in  two  phases.  The  purpose  of  Phase  1  is  to 
describe  menstrual  experiences  of  women  who  have  been  deployed  to  a  military  theater  of 
operations  and  to  explore  their  experiences  with  menstrual  suppression.  Phase  1  research 
questions  are:  (1)  How  do  military  women  manage  menses  while  deployed?  (2)  How  do  military 
women  feel  about  using  continuous  oral  contraceptives  for  suppression  of  menses  while  they  are 
deployed? 

The  purpose  of  Phase  2,  pilot  instrument  development  and  testing,  is  to  generate  an  instrument 
that  measures  military  women's  attitudes  towards  menstruation  and  menstrual  suppression. 

Phase  2  research  questions  are:  (1)  What  are  the  initial  psychometric  properties  of  the  instrument? 
(2)  To  what  extent  is  further  use  of  the  instrument  feasible? 

Technical  Approach:  Phase  1,  Interviews:  A  qualitative  descriptive  approach  will  be  utilized  to 
explore  attitudes  towards  menstruation  and  menstrual  suppression  among  military  women  who 
have  returned  from  a  deployment  to  a  theater  of  military  operations.  The  projected  sample  size  is 
30  women,  or  until  themes  become  repetitive.  Data  Collection:  Sampling  will  occur  at  the  Fort 
Lewis  SRP  site.  Subjects  will  participate  in  a  focused  interview  utilizing  open-ended  questions 
which  have  been  derived  from  a  review  of  literature.  Questions  will  be  focused  on  the  experiences 
of  menstruation  and  suppression  of  menstruation  using  continuous  oral  contraceptives  while  in  a 
deployed  environment.  The  interviews  will  be  limited  to  30  minutes,  being  cognizant  of  the  time 
constraints  on  these  women's  live.  The  interviews  will  be  conducted  in  a  private  area  within  the 
SRP  site.  The  data  will  be  audio  tape  recorded  and  transcribed  verbatim  by  either  a  qualified 
transcriptionist  or  the  PI.  Data  Analysis:  Inductive  content  analysis  will  be  conducted  to 
determine  themes  which  describe  the  menstrual  experiences  and  suppression  of  menses,  as  it  is 
applicable,  of  deployed  women. 

Phase  2,  Instrument  development:  The  Phase  1  themes  will  be  utilized  in  the  construction  of  a 
military-specific  tool  to  measure  military  women's  menstrual  attitudes  and  their  attitudes  towards 
menstrual  suppression  during  deployment.  Items  for  the  measure  will  be  generated  based  on 
themes  from  the  interviews.  A  women's  health  expert  panel,  will  be  consulted  during  item 
generation.  Content  validity  will  be  determined  by  both  the  women's  health  expert  panel  and  a  lay 
panel,  which  will  consist  of  military  women.  Revisions  to  the  instrument  will  be  made  based  on 
content  validity  assessments.  The  expert  panel  will  again  be  consulted.  The  final  step  of 
instrument  development  is  a  pilot  test  of  the  instrument  on  50-60  women.  The  sample  will  be  from 
the  SRP  site.  Recruitment  will  occur  in  the  same  manner  as  with  the  interviews.  The  instrument 
will  be  administered  in  a  private  area  of  the  SRP.  A  face  validity  assessment  will  be  included  with 
the  instrument  for  the  pilot  subjects  to  complete.  The  pilot  data  will  be  analyzed  for  reliability  and 
feasibility.  Based  on  the  results  of  the  pilot  data,  the  instrument  will  be  revised  and  ready  for 
future  study.  The  future  study  would  determine  the  instrument's  validity  and  reliability. 


248 


Progress:  Phase  2,  "Instrument  Development,"  has  been  conducted.  Based  on  the  results  of 
Phase  1,  the  instrument,  "Military  Women's  Attitudes  Towards  Menstrual  Suppression"  was 
revised  and  pilot  tested  according  to  protocol  procedures.  Data  analysis  was  performed  according 
to  protocol  and  the  instrument  was  found  to  have  sufficient  reliability  and  validity  for  future 
study.  Refer  to  protocol  #206107  for  next  study  in  the  development  of  this  instrument.  This 
protocol  was  reported  as  completed  during  FY  2006. 


249 


Detail  Summary  Sheets 

Anesthesia  Students,  Department  of  Nursing 


250 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204112  Status:  Completed 

Title:  Efficacy  of  Preoperative  Valerian  (Night  Before)  on  Day  of  Surgery  Anxiety 
Principal  Investigator:  CPT  Mary  K.  Hannon,  AN 

Department:  Nursing/ Anesthesia  Facility:  MAMC 

Associate  Investigator(s):  CPT  Angela  M.  Downs,  AN;  Mark  D.  Hachey,  CRNA 

Start  -  Completion:  Funding:  Periodic  Review: 

11/5/2004  -  Oct  2005  DCI  8/23/2005 

Study  Objective:  To  determine  if  valerian  reduces  anxiety  in  patients  undergoing  general  or 
regional  anesthesia  when  administered  the  night  before  surgery. 

Technical  Approach:  Recruitment:  Identification  of  potential  candidates  for  participation  in  the 
study  will  be  accomplished  by  prescreening  of  the  surgical  roster,  and  identified  candidates 
recruited  during  the  pre-anesthesia  interview.  CPT  Angela  Downs  or  CPT  Mary  Kate  Hannon  will 
complete  consent  after  the  pre-anesthesia  interview.  Informed  consent  will  be  obtained  prior  to  the 
administration  of  any  of  the  anxiety  measuring  instruments  (VAS/SAI).  Upon  collection  of 
demographic  data,  a  standardized  direction  and  information  statement  will  be  read  to  each 
participant.  Once  the  participant  verbalizes  understanding  of  the  process,  the  SAI  and  VAS  in 
relation  to  anxiety  of  the  upcoming  surgery  will  be  administered.  The  principle  or  associate 
investigators  will  be  present  in  the  room  for  this  process  to  answer  any  questions,  and  to  collect 
and  secure  the  data.  Randomization  of  test  subjects  will  be  accomplished  by  pre-prepared  chart 
calculated  by  Mr.  Troy  Patience  of  the  Department  of  Clinical  Investigations,  MAMC  using 
Microsoft  Excel.  Patients  will  receive  either  placebo,  or  800mg  active  valerian  according  to  the 
randomization  chart.  Each  day  investigators  will  sign  out  approximately  15  doses  of  the  pre¬ 
numbered  standard  plastic  prescription  vials  containing  the  valerian  or  placebo.  Distribution  will 
be  accomplished  by  the  investigators  during  the  preoperative  interview.  An  instruction  sheet 
explaining  possible  side  effects  of  this  medication  will  be  provided  to  the  subjects,  as  well  as 
instructions  if  a  suspected  allergic  reaction  or  acute  side  effects  occur.  The  time  frame  of  actual 
administration  will  be  approximately  2200  hrs  the  night  before  surgery,  or  at  the  hour  of  sleep,  in 
accordance  with  other  surgical  restrictions,  i.e.,  NPO  after  midnight. 

Re-evaluation  of  test  subjects:  Participants  will  be  asked  to  repeat  both  the  VAS  and  SAI  forms 
while  in  the  preoperative  holding  area  and  prior  to  the  insertion  of  IV  catheter(s)  or  any  other 
surgical  adjunct.  Either  investigator  will  again  collect  the  VAS  and  SAI  form  data  assuring 
consistency  and  confidentiality.  Outcome  variables  are  the  level  of  anxiety  that  will  be  measured 
using  the  STAI-S  questionnaire  and  VAS,  with  an  anticipated  reduction  in  the  level  of  anxiety  in 
individuals  taking  the  800mg  valerian  versus  the  placebo.  Differences  between  groups  will  be 
determined  by  a  statistical  analysis  of  the  SAI  and  the  VAS  scores  separately  using  Analysis  of 
Covariance. 

Progress:  This  protocol  was  reported  as  completed  in  October  2005,  with  143  subjects  enrolled. 
Findings:  Under  the  conditions  of  this  study,  there  were  no  significant  differences  between  the  pre 
and  post  SAI  and  VAS  for  either  the  placebo  or  valerian  group.  Serendipitously,  the  investigators 
found  a  significant  difference  in  preoperative  anxiety  between  males  and  females.  Postulated 
reasons  there  was  no  significant  difference  (1)  valerian  has  no  efficacy,  (2)  timing  of  dose 
administration  and  post  test,  (3)  dose  of  valerian  administered,  (4)  single  dose  versus  multiple 
doses,  and  (5)  influence  of  gender  roles  on  anxiety. 


251 


Detail  Summary  Sheets 

Department  of  Obstetrics/Gynecology 


252 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206042  Status:  Completed 

Title:  Resident  Training  in  Assessment  of  the  Sexual  Assault  Patient  Utilizing  Simulation 
Principal  Investigator:  CPT  Anne  C.  Burris,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Shad  H.  Deering,  MC;  LTC  Michael  K.  Chinn,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/6/2006  -  Jan  2006  DCI  N/A 

Study  Objective:  The  objective  is  to  evaluate  the  use  of  a  simulation-based  training  program  on 
resident  comfort  with  and  understanding  of  evaluation  of  a  sexually  assaulted  patient. 

Technical  Approach:  This  study  plans  to  utilize  the  NOELLE  childbirth  simulator  module  at  the 
Anderson  Simulation  Center  to  both  evaluate  resident  performance  of  the  evaluation  of  a  sexual 
assault  patient  as  well  as  investigate  their  comfort  level  with  the  procedure.  This  evaluation  is  to 
be  done  before  and  after  simulation  testing  to  see  if  this  is  a  helpful  model  that  should  be 
incorporated  into  our  standard  simulation  curriculum. 

Progress:  Results:  After  training,  residents  reported  that  they  had  a  better  understanding  of  the 
procedure  for  the  examination,  what  medications  should  be  given  for  STD  prophylaxis,  what 
anatomic  findings  must  be  recorded,  and  the  chain  of  custody  that  must  be  maintained. 
Conclusions:  A  simulation-based  course  can  improve  resident  confidence  with  the  performance  of 
the  examination  of  a  sexual  assault  patient.  This  training  is  especially  important  in  the 
explanation  of  the  requirements  for  the  collection  of  evidence. 


253 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205140  Status:  Ongoing 

Title:  Continuous  Use  of  the  Oral  Contraceptive  for  Menstrual  Cycle  Suppression  and  the 
Effects  on  Bone  Density;  a  Prospective,  Randomized,  Clinical  Trial 

Principal  Investigator:  ETC  Michael  K.  Chinn,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  Leslie  Miller,  M.D.;  LTC  Antonio  G.  Balingit,  MC;  Nancy  A. 
Poffenberger,  PAC,  Ph;  COL  Diane  M.  Flynn,  MC;  LTC  Wendy  Ma,  MC;  LTC  Jeffery  L.  Clemons, 
MC;  COL  Jon  A.  Proctor,  MC;  Gregory  E.  Chow,  MD;  CPT  Tammy  J.  Mantzouris,  MC;  CPT 
Andrew  E.  Fong,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/13/2006  -  Dec  2011  DCI  10/19/2006 

Study  Objective:  To  identify  the  dose  of  ethinyl  estradiol  (EE)  in  combination  with  levonorgestrel 
(LNG)  or  norethindrone  acetate  (NETA)  that,  when  taken  daily,  results  in  rapid  and  sustained 
amenorrhea  over  two  years  with  minimal  changes  in  bone  density. 

Technical  Approach:  This  study  looks  at  what  pill  dose,  when  taken  every  day,  will  work  the 
fastest  to  stop  all  period  bleeding  and  which  dose  will  keep  the  bleeding  away  for  two  years  of  daily 
use.  Women  will  provide  a  monthly  report  of  pill  use  and  bleeding  and  have  their  bone  density 
measured  at  baseline  and  after  two  years  to  see  if  the  two  estrogen  doses  or  two  progestin  types 
will  vary  these  and  other  safety  effects.  In  addition,  women  stopping  the  study  drug  will  be 
followed  until  menstruation  returns  to  document  reversibility.  Female  soldiers  need  to  know  which 
dose  of  birth  control  pill  can  induce  menstrual  cycle  suppression,  the  safety  of  taking  these  pills 
every  day  for  up  to  2  years,  the  effects  of  an  induced  amenorrhea  on  their  bone  density,  and  the 
time  it  takes  for  menses  to  return  following  suppression. 

Progress:  Initiation  of  this  protocol  is  pending  funding.  An  amendment  was  submitted  due  to  an 
offer  of  fewer  funds  than  requested.  The  study  has  changed  from  a  four  arm  to  a  two  arm  trial 
looking  at  the  lower  estrogen  doses.  Enrollment  was  dropped  from  720  to  360,  and  length  of 
subject  involvement  shortened  from  24  to  18  months.  The  study  also  would  no  longer  be  providing 
menstrual  hygiene  products  to  subjects  or  be  able  to  hire  a  study  provider  (ARNP);  just  a  dedicated 
research  coordinator. 


254 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  81035  Status:  Ongoing 

Title:  GOG  0041:  Surgical  Staging  of  Ovarian  Carcinoma 
Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/16/1981  -  Indef  GOG  9/21/2006 

Study  Objective:  To  determine  the  spread  of  ovarian  carcinoma  to  intraperitoneal  structures  and 
retroperitoneal  lymph  nodes  by  direct  examination,  cytologic  sampling,  and  biopsy;  to  establish  a 
surgical  protocol  for  patients  entered  into  GOG  ovarian  cancer  treatments  protocols;  to  determine 
the  complication  rate  of  the  procedures. 

Technical  Approach:  This  protocol  is  being  performed  as  a  statistical  protocol  on  patients  who 
have  surgery  as  standard  treatment.  Eligible  patients  will  be  those  who  have  Stages  I,  II,  or  III 
ovarian  carcinoma.  Patients  undergoing  total  abdominal  hysterectomy,  bilateral  or  unilateral 
salpingo-oophorectomy,  bivalving  of  the  ovary,  selective  pelvic  and  para-aortic  lymphadenectomy, 
omental  biopsy,  or  peritoneal  cytology  sampling  will  be  studied.  They  will  not  be  given  any 
preoperative  treatment,  but  will  be  subjected  to  a  complete  and  thorough  evaluation  before 
surgery.  All  patients  will  be  explored  and  the  steps  for  surgery  will  be  as  standard  surgery 
dictates.  Specific  observations  will  be  made  as  to  the  findings.  If  fluid  is  not  present,  washings  will 
be  taken  from  the  inside  of  the  abdomen  to  study  cells.  A  thorough  examination  of  all  structures 
from  the  diaphragm  to  the  pelvic  floor  will  be  carried  out.  After  surgical  staging,  patients  will  be 
transferred  to  the  appropriate  treatment  protocol  or  to  standard  treatment  if  no  protocol  is 
available. 

Progress:  This  protocol  closed  to  patient  entry  in  February  1987,  with  thirteen  patients  enrolled. 
Three  patients  remain  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06.  Final 
analysis  of  this  trial  appears  in  the  January  1988  GOG  Statistical  Report.  The  manuscript  derived 
from  this  trial  was  published  in  Surg.  Gynecol.  Obstet  1989. 


255 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  81105  Status:  Ongoing 

Title:  GOG  0052:  A  Phase  III  Randomized  Study  of  Cyclophosphamide  Plus  Adriamycin  Plus 
Platinol  Versus  Cyclophosphamide  Plus  Platinol  in  Patients  with  Optimal  Stage  II  Ovarian 
Adenocarcinoma 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

8/21/1981  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  determine,  in  optimal  Stage  III  ovarian  adenocarcinoma,  if  the  addition  of 
adriamycin  to  cyclophosphamide  plus  cis-platinum  improves  progression-free  interval,  frequency  of 
negative  second-look  laparotomy  and  survival.  This  protocol  replaces  GOG  0025. 


Technical  Approach:  Eligible  patients  are  those  more  than  six  weeks  post-operative  with  proven 
primary  Stage  III  ovarian  adenocarcinoma  confined  to  the  abdominal  cavity  and  its  peritoneal 
surfaces  with  residual  tumor  masses  after  surgery  no  larger  than  1  cm  in  diameter.  Patients  with 
prior  chemo  or  radiotherapy  are  ineligible.  Patients  will  be  randomized  to  cyclophosphamide  plus 
Platinol  every  three  weeks  for  eight  courses  or  to  cyclophosphamide  and  Platinol  plus  adriamycin 
every  three  weeks  for  eight  courses.  After  eight  courses  those  with  less  than  clinically  complete 
response  will  go  off  study  and  be  followed  for  survival;  those  with  clinically  complete  response  will 
have  second-look  surgery  to  validate  the  complete  response  or  to  remove  residual  tumor  masses. 
Patients  will  then  be  followed  for  approximately  five  years  for  survival  rates. 

Progress:  This  protocol  closed  to  patient  entry  in  July  1985,  with  six  patients  enrolled.  One 
patient  remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06.  Final  analysis  of 
the  study  appears  in  the  July  1988  GOG  statistical  report.  Seven  abstracts  and  publications  (listed 
in  the  GOG  statistical  report)  evolved  from  this  clinical  trial. 


256 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  84033  Status:  Ongoing 

Title:  GOG  0072:  Ovarian  Tumors  of  Low  Malignant  Potential:  A  Study  of  the  Natural  History 
and  a  Phase  II  Trial  of  Melphalan  and  Secondary  Treatment  with  Cisplatin  in  Patients  with 
Progressive  Disease 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

2/17/1984  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  evaluate  the  biologic  behavior  of  ovarian  tumors  of  low  malignant  potential; 
to  evaluate  the  effectiveness  of  chemotherapy  against  this  disease  (initially,  a  Phase  II  study  of 
melphalan);  and  to  evaluate  the  response  rate  to  cisplatin  in  melphalan  failures. 


Technical  Approach:  Patients  without  prior  chemotherapy  of  radiotherapy  who  have  had 
adequate  surgical  staging  will  be  eligible.  Patients  with  no  grossly  visible  residual  disease  will 
receive  no  treatment  and  be  followed  for  five  years  if  there  is  no  subsequent  disease.  If  there  is  no 
grossly  visible  clinically  apparent  residual  for  12  months,  the  patients  will  have  second  look 
surgery  and  then  proceed  to  melphalan  treatment  (5  days  every  four  weeks)  or  follow-up  (complete 
response).  With  progression  after  melphalan,  patients  will  proceed  to  third  look  and  cisplatin 
treatment  (once  every  three  weeks  for  eight  weeks)  or  follow-up.  If  there  is  no  evidence  of  response 
after  three  courses  of  cisplatin,  the  treatment  will  be  discontinued.  Patients  who  have  progression 
during  the  first  12  months  will  be  treated  as  above  except  they  will  proceed  directly  to  melphalan 
treatment  without  second  look  surgery.  Follow-up  will  be  for  a  minimum  of  five  years  with  clinical 
examination  every  three  months  for  the  first  two  years,  then  every  six  months  thereafter. 

Progress:  This  protocol  closed  to  patient  entry  in  February  1992,  with  ten  patients  enrolled.  Five 
patients  continued  to  be  followed  at  MAMC  during  FY06,  three  patients  have  been  lost  to  follow¬ 
up  and  two  patients  with  no  evidence  of  disease  continue  to  be  followed  out-of-state.  Statistical 
analysis  appears  in  the  July  2002  GOG  Statistical  Report.  Manuscript  derived  from  this  trial  was 
published  in  JCO  1995. 


257 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  84074  Status:  Ongoing 

Title:  GOG  0078:  Evaluation  of  Adjuvant  VP-16,  Bleomycin,  and  Cisplatin  (BEP)  Therapy  in 
Totally  Resected  Choriocarcinoma,  Endodermal  Sinus  Tumor,  Embryonal  Carcinoma  and  Grade 
3  Immature  Teratoma  of  the  Ovary,  Pure  and  Mixed  with  Other  Elements 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

8/17/1984  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  evaluate  the  effect  of  adjuvant  vinblastine,  bleomycin,  and  cisplatin  (VBP) 
chemotherapy  in  patients  with  endodermal  sinus  tumor  and  choriocarcinoma  of  the  ovary  (pure 
and  mixed)  after  removal  of  all  gross  tumor;  to  evaluate  the  role  of  serum  markers,  especially 
alpha  fetoprotein  and  HCG,  in  predicting  recurrence;  to  evaluate  the  role  of  reassessment 
laparotomy  in  determining  response,  detecting  early  relapse,  and  planning  further  therapy;  and  to 
compare  the  biologic  behavior  of  pure  endodermal  sinus  tumors  with  mixed  germ  cell  tumors 
containing  endodermal  sinus  elements.  Per  addendum  of  Jan.  87:  to  evaluate  the  acute  and 
chronic  toxicity  of  this  chemotherapy  on  gonadal  and  reproductive  function. 

Technical  Approach:  Patients  with  totally  resected  Stage  I  choriocarcinoma,  endodermal  sinus 
tumor,  or  embryonal  carcinoma  of  the  ovary  with  negative  peritoneal  washings,  normal  (or  falling 
at  a  rate  that  does  not  suggest  residual  disease)  serum  AFP  and  beta-HCG  levels,  and  adequate 
bone  marrow,  renal,  and  hepatic  function  will  be  studied.  Stages  II  and  III  will  also  be  eligible  if 
all  gross  tumor  is  resected.  After  recovery  from  surgery,  patients  will  receive  3  cycles  of  VBP 
therapy.  Patients  who  show  evidence  of  progression  while  on  VBP  therapy  will  be  candidates  for 
GOG  Protocol  26.  Patients  completing  three  cycles  of  treatment  clinically  free  of  disease  will 
undergo  reassessment  laparotomy.  Patients  with  recurrent  disease  at  reassessment  laparotomy 
will  be  candidates  for  GOG  Protocol  26.  To  be  eligible  a  patient  will  receive  at  least  one  week  of 
chemotherapy  and  live  another  two  weeks.  Each  patient  will  remain  on  study  until  adverse  effects 
prohibit  further  therapy  or  until  evidence  of  progression  is  noted.  Per  addendum  of  Jan.  86:  the 
title  has  been  changed  as  shown  above;  vinblastine  has  been  replaced  by  VP- 16;  Grade  3  immature 
teratoma  has  been  added  for  entry  and  evaluation. 

Progress:  This  protocol  closed  to  patient  entry  in  February  1992,  with  one  patient  enrolled  who 
remains  disease-free  with  a  last  follow-up  (out-of-state)  in  FY02.  Final  analysis  of  this  study 
appears  in  the  July  1993  GOG  Statistical  Report.  Manuscripts  derived  from  this  clinical  trial  had 
been  published  in  1994. 


258 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  86089  Status:  Ongoing 

Title:  GOG  0085:  A  Randomized  Comparison  of  Hydroxyurea  versus  5-FU  Infusion  and  Bolus 
Cisplatin  as  an  Adjuvant  to  Radiation  Therapy  in  Patients  with  Stages  II-B,  III,  and  IV-A 
Carcinoma  of  the  Cervix  and  Negative  Para-Aortic  Nodes 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

9/19/1986  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  determine  whether  hydroxyurea  or  the  combination  of  5-FU  and  cisplatin  is 
superior  as  a  potentiator  of  radiation  therapy  in  advanced  cervical  carcinoma  and  to  determine  the 
relative  toxicities  of  hydroxyurea  versus  the  combination  of  5-FU  and  cisplatin  when  given 
concurrently  with  radiation  therapy. 

Technical  Approach:  Patients  with  invasive  squamous  cell,  adenocarcinoma,  or  adenosquamous 
carcinoma  of  the  cervix,  Stages  II-B,  III,  and  IV-A,  who  meet  the  eligibility  requirements  as  listed 
in  the  protocol,  will  undergo  clinical  staging  as  permitted  by  FIGO  rules.  All  patients  will  undergo 
surgical  staging  to  include  extraperitoneal  sampling  of  the  para-aortic  lymph  nodes,  peritoneal 
cytology,  and  intraperitoneal  exploration.  Patients  with  cancer  confined  to  the  pelvis  will  receive 
pelvic  irradiation  and  will  be  randomly  assigned  to  receive  either  concomitant  5-FU  and  cisplatin 
or  hydroxyurea.  Patients  with  disease  outside  the  pelvis  are  not  eligible  for  this  protocol.  The 
study  will  continue  as  long  as  treatment  protocols  remain  activated.  The  patients  will  be  followed 
for  two  years  and  then  every  six  months  for  three  additional  years. 

Progress:  This  protocol  closed  to  patient  entry  in  December  1990,  with  two  patients  were 
enrolled.  One  patient  was  lost  to  follow-up  (last  seen  at  MAMC  in  1985).  The  second  patient  has 
been  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06.  Final  statistical  analysis 
appears  in  the  July  1997  GOG  Statistical  Report.  Two  abstracts  and  a  publication  (listed  in  the 
GOG  statistical  report)  have  been  derived  from  this  clinical  trial. 


259 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  87104  Status:  Ongoing 

Title:  GOG  0092:  Treatment  of  Selected  Patients  with  Stage  IB  Carcinoma  of  the  Cervix  After 
Radical  Hysterectomy  and  Pelvic  Lymphadenectomy:  Pelvic  Radiation  Therapy  versus  No 
Further  Therapy 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

8/21/1987  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  determine  the  value  of  adjunctive  pelvic  radiation  in  the  treatment  of  Stage 
IB  carcinoma  of  the  cervix  but  with  selected  high-risk  factors;  to  determine  the  recurrence-free 
interval,  survival  and  patterns  of  failure  in  those  patients;  and  to  determine  the  morbidity  of 
adjunctive  pelvic  radiation  following  radical  hysterectomy. 

Technical  Approach:  All  patients  with  Stage  IB  cancer  of  the  cervix  who  have  been  treated  by 
radical  hysterectomy  and  pelvic  node  dissection  and  found  to  have  cancer  confined  to  the  cervix 
and  who  have  a  large  tumor  and/or  lymph  or  blood  vessel  invasion  in  the  cervix  will  be  eligible  to 
enter  the  study.  Patients  will  be  randomized  to  one  of  two  groups.  One  group  will  receive  external 
radiation  therapy  to  the  pelvis  and  the  other  group  will  receive  no  further  therapy.  Patients 
assigned  to  receive  the  radiation  therapy  will  receive  the  therapy  daily  for  4  to  6  weeks.  Both 
groups  of  patients  will  be  required  to  have  check-ups  every  three  months  for  three  years  and  then 
every  six  months  for  two  more  years. 

Progress:  This  protocol  closed  to  patient  entry  in  December  1995,  with  one  patient  enrolled  in  FY 
1988,  who  remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06.  Final 
analysis  appears  in  the  January  1999  GOG  Statistical  Report.  An  abstract  and  publication  have 
been  derived  from  this  clinical  trial. 


260 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  87028  Status:  Ongoing 

Title:  GOG  0095:  Randomized  Clinical  Trial  for  the  Treatment  of  Women  with  Selected  Stage  IC 

and  II  (A,B,C)  and  Selected  IAi  and  IBi  and  IAii  and  IBii  Ovarian  Cancer,  Phase  III 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/21/1986  -  Indef  GOG  9/21/2006 

Study  Objective:  In  definitively  staged  patients  who  have  tumor  involving  one  or  both  ovaries 
with  pelvic  extension  and/or  malignant  ascites  and/or  positive  peritoneal  washings  and  in  those 
Stage  IAi  and  IBi  patients  with  poorly  differentiated  tumors  and  stage  IAii  and  IBii  (all  grades)  to: 
compare  the  progression-free  interval  and  overall  survival  of  the  two  treatment  regimens; 
determine  the  patterns  of  relapse  for  each  form  of  therapy;  and  define  the  relative  toxicities  of  the 
two  treatment  approaches. 

Technical  Approach:  The  study  design  will  be  a  randomized  comparison  between  the  standard 
adjuvant  treatment  (P32)  and  an  experimental  arm  of  short  term  intensive  adjuvant  combination 
chemotherapy  with  cyclophosphamide/cisplatin  in  patients  with  ovarian  cancer.  One  to  two  weeks 
following  surgery,  P32  therapy  will  be  started.  Fifteen  millicuries  of  chromic  phosphate  suspension 
mixed  in  500  cc  of  normal  saline  will  be  infused  into  the  peritoneal  cavity  via  the  peritoneal 
dialysis  catheter  after  a  technetium  scan  or  abdominal  x-rays  with  contrast  material  has 
demonstrated  adequate  distribution.  In  order  to  facilitate  distribution  of  the  P32,  the  patient  will 
be  turned  every  15  minutes  to  the  left  side,  onto  the  back,  in  Trendelenburg  and  reverse 
Trendelenburg  positions,  onto  the  right  side  and  so  on  for  two  hours  following  the  infusion. 
Chemotherapy  will  consist  of  cyclophosphamide,  1  mg/m2  I.V.,  on  day  1  plus  cisplatin,  100  mg/m 
IV,  on  day  1  administered  one  hour  after  cyclophosphamide.  Cycles  of  combination  chemotherapy 
will  be  repeated  every  three  weeks  depending  upon  the  time  to  recovery  of  the  blood  counts  to 
pretreatment  level.  Cycles  of  chemotherapy  will  be  repeated  for  a  total  of  three  cycles.  Patient 
follow-up  will  continue  until  death,  loss  of  follow-up,  or  termination  of  the  study.  Patients  will 
remain  on  study  until  disease  progression  or  adverse  effects  dictate  otherwise.  An  adequate  trial  is 
defined  as  receipt  of  at  least  one  course  of  therapy  and  one  follow-up  visit. 

Progress:  This  protocol  closed  to  patient  entry  in  March  1994,  with  five  patients  enrolled.  One 
patient  remains  disease  free  and  continued  to  be  followed  at  MAMC  during  FY06.  Final  analysis  of 
this  trial  appears  in  the  July  2000  GOG  Statistical  Report.  Abstracts  and  manuscripts  derived 
from  this  trial  have  been  published  as  listed  in  the  GOG  Statistical  Report. 


261 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  87091 

Status:  Ongoing 

Title:  GOG  0099:  A  Phase  III  Randomized  Study  of  Adjunctive  Radiation  Therapy  in 

Intermediate  Risk  Endometrial  Adenocarcinoma 

Principal  Investigator:  ETC  Louis  A.  Dainty,  MC 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  ETC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

7/17/1987  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  determine  if  patients  with  intermediate  risk  endometrial  adenocarcinoma 
who  have  no  spread  of  disease  to  the  lymph  nodes  benefit  from  postoperative  pelvic  radiotherapy 
and  to  evaluate  how  the  addition  of  pelvic  radiotherapy  will  alter  the  site  and  rate  of  cancer 
recurrence  in  these  intermediate  risk  patients. 

Technical  Approach:  Patients  with  primary  histologically  confirmed  Grade  2  or  3  endometrial 
adenocarcinoma  (endometrioid,  villoglandular,  mucinous  and  adenosquamous)  and  clear  cell 
carcinoma  will  be  eligible.  Patients  must  have  had  a  total  abdominal  hysterectomy,  bilateral 
salpingo-oophorectomy,  selective  pelvic  and  para-aortic  node  sampling,  pelvic  washings  and  found 
to  be  surgical  Stage  1  with  myometrial  invasion.  Following  surgery,  patients  will  be  randomized  to 
no  additional  treatment  of  pelvic  radiation  therapy  to  begin  no  later  than  eight  weeks  after 
surgery.  Those  randomized  to  radiation  therapy  will  be  treated  with  AP  and  PA  parallel  ports  with 
each  port  being  treated  each  day.  A  daily  tumor  dose  of  180  cGy  will  be  given  to  a  total  dose  of 
5040  cGY  in  approximately  six  weeks.  Each  patient  will  be  followed  with  regular  visits  occurring 
every  three  months  for  the  first  two  years,  every  six  months  for  the  third,  fourth  and  fifth  years, 
and  yearly  thereafter. 

Progress:  This  protocol  closed  to  patient  entry  in  July  1995,  with  three  patients  enrolled.  All  are 
clinically  disease  free  and  continued  to  be  followed  during  FY06.  Final  analysis  appears  in  the 
January  1999  GOG  Statistical  Report.  Two  abstracts  were  published.  Manuscript  derived  from 
this  clinical  trial  is  under  revision  for  publication. 


262 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  93063  Status:  Ongoing 

Title:  GOG  0123:  A  Randomized  Comparison  of  Radiation  Therapy  &  Adjuvant  Hysterectomy  vs 
Radiation  Therapy  &  Weekly  Cisplatin  &  Adjuvant  Hysterectomy  in  Patients  with  Bulky  Stage 
IB  Carcinoma  of  the  Cervix 

Principal  Investigator:  LTC  Louis  A.  Dainty,  MC 


Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Jane  Shen-Gunther,  MC 

Start  -  Completion:  Funding: 

5/6/1994  -  Indef  GOG 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  evaluate  the  addition  of  weekly  chemotherapy  with  Cisplatin  during 
radiation  therapy  in  patients  with  bulky  Stage  IB  carcinoma  of  the  cervix. 


Technical  Approach:  This  study  randomizes  patients  to  two  different  treatment  regimens.  Both 
regimens  include  radiation  therapy  followed  by  hysterectomy.  Regimen  I  -  Radiation  Therapy  Plus 
Adjuvant  Hysterectomy  -  Patients  will  undergo  combined  external  and  intracavitary  radiation 
therapy  followed  by  extrafascial  hysterectomy  (total  doses  of  13000  cGy).  Regimen  II  -  Radiation 
Therapy  Plus  Weekly  Cisplatin  Infusion  Plus  Extrafascial  Hysterectomy.  Patient  will  undergo 
radiation  therapy  to  receive  a  total  dose  of  13000  cGy  using  a  combination  of  external  and 
intracavitary  radiation  therapy.  Each  week  during  external  radiation  therapy  and  during  the 
intracavitary  applications  the  patient  will  receive  an  infusion  of  cisplatin  40  mg/m2  not  to  exceed 
70  mg  maximum  in  any  single  infusion,  up  to  a  maximum  of  6  doses  of  cisplatin.  Extrafascial 
hysterectomy  will  be  carried  out  no  later  than  six  weeks  following  the  last  day  of  treatment  in  both 
regimens. 

The  principal  parameters  to  determine  the  efficacy  of  weekly  cisplatin  during  radiotherapy 
are:  1)  Outcome  variables  (recurrence-free  interval  (RF),  survival  and  local  control  rate);  2)  Tumor 
characteristics;  3)  Host  characteristics;  4)  Adverse  effects;  5)  Therapy  administered. 

Progress:  This  protocol  closed  to  patient  entry  in  April  1997,  with  one  patient  enrolled  who 
remains  disease  free  and  continued  to  be  followed  during  FY06. 


263 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206029  Status:  Ongoing 

Title:  Simulation  Training  for  Postpartum  Hemorrhage 
Principal  Investigator:  MAJ  Shad  H.  Deering,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion:  Funding:  Periodic  Review: 

12/14/2005  -  Jan  2006  DCI  N/A 

Study  Objective:  To  have  OB/GYN  residents  perform  a  simulated  postpartum  hemorrhage 
scenario  to  evaluate  their  clinical  management  skills  and  evaluate  a  standardized  grading  form. 

Technical  Approach:  A  standard  postpartum  hemorrhage  simulation  has  been  designed  using 
the  NOELLE  mannequin  and  the  new  uterine  hemorrhage  model  at  the  Anderson  Simulation 
Center  (designated  for  use  by  OB/GYN).  Standardized  objective  and  subjective  evaluation  sheets 
have  been  created  to  evaluate  resident's  performance.  Prior  to  beginning  the  simulation,  residents 
will  be  given  a  case  scenario  describing  the  patient's  clinical  situation.  Residents  will  enter  the 
room  and  address  the  active  bleeding  that  is  occurring.  All  simulations  will  be  digitally  recorded 
with  at  least  two  evaluators  present  to  assess  the  resident's  performance  using  the  standard 
evaluation  forms.  Residents  will  be  able  to  perform  an  examination  and  ask  for  medications  to  be 
administered.  An  empty  syringe  will  be  used  by  a  staff  member  playing  the  part  of  the  nurse  to 
"administer"  any  medications  requested  and  the  resident  will  be  made  to  clarify  the  dose  and  route 
of  the  medication.  The  simulation  will  end  when  the  resident  has  performed  an  appropriate 
physical  examination,  fundal  massage,  and  administered  two  medications  in  the  correct  dose  and 
route,  or  when  a  total  of  5  minutes  has  expired.  After  the  simulation,  the  resident  will  be  shown 
their  grading  scores  and  additional  instruction  will  be  performed  in  any  areas  that  were  deficient. 

Progress:  This  protocol  remains  ongoing  with  fourteen  residents  from  MAMC  who  took  part  in 
this  study  during  FY06.  All  fourteen  completed  the  simulation  training  protocol  and  data  analysis 
is  currently  being  conducted. 


264 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206098 

Status:  Ongoing 

Title:  Serum  Estradiol  Levels  in  Patients  with  Polycystic  Ovarian  Syndrome  undergoing 
Ovulation  Induction  with  Clomiphene  Citrate 

Principal  Investigator:  CPT  Shannon  K.  Flood,  MC 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  COL  Jon  A.  Proctor,  MC 

Start  -  Completion:  Funding: 

6/5/2006  -  May  2007  DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  correlate  serum  estradiol  levels  and  ovulation  rates  in  patients  with 
polycystic  ovarian  syndrome  undergoing  ovulation  induction  with  clomiphene  citrate. 


Technical  Approach:  This  is  a  prospective  observational  study  to  analyze  the  relationship 
between  serum  estradiol  levels  and  ovulation  rates  in  women  with  polycystic  ovarian  syndrome 
undergoing  ovulation  induction  with  clomiphene  citrate.  Women  enrolled  in  the  study  will  take 
50-250  mg  of  clomiphene  citrate  on  days  3-7  or  days  5-9  of  their  menstrual  cycle.  They  will  also 
present  for  transvaginal  ultrasound  and  a  serum  estradiol  levels  on  menstrual  cycle  day  12,  13,  or 
14.  Patients  will  be  provided  with  urinary  lutenizing  hormone  detection  kits,  and  will  be 
instructed  to  record  the  day  of  their  LH  surge.  Lastly,  patients  will  obtain  a  serum  progesterone 
concentration  seven  days  after  their  LH  surge.  This  data  will  be  organized  in  a  spreadsheet 
format.  The  study  participants  will  then  be  divided  into  two  groups,  those  who  ovulated  and  those 
who  did  not.  Mean  estradiol  levels  will  then  be  calculated  for  each  group.  Appropriate  post  hoc 
statistical  analysis  will  then  be  performed  to  evaluate  for  any  correlation  between  estradiol  levels 
and  ovulation  rates. 

Progress:  A  total  of  4  patients  have  enrolled  in  the  study  at  MAMC  during  FY06.  The  study  has 
been  temporarily  on  hold  with  COL  Proctor's  retirement  this  summer,  and  I  myself  (the  PI)  have 
been  on  an  off  service  rotation  and  have  been  unable  to  consent  patients.  However,  I  plan  on 
adding  the  REI  specialist,  COL  Chow,  to  the  protocol  and  starting  enrolling  new  patients  shortly. 


265 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  99077  Status:  Completed 

Title:  Misoprostol  for  the  Medical  Management  of  Non-viable  First  Trimester  Pregnancies 

Principal  Investigator:  CPT  Jasmine  J.  Han,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  COL  Peter  E.  Nielsen,  MC;  Troy  H.  Patience,  B.S.;  COL  Milo  L. 

Hibbert,  MC;  MAJ  Jason  D.  Parker,  MC;  CPT  Robert  G.  Fowers,  MC;  LTC  Louis  A.  Dainty,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

3/9/2000  -  Mar  2001  DCI  6/20/2006 

Study  Objective:  The  purpose  of  this  study  is  to  examine  the  effectiveness  of  Misoprostol 
(Cytotec;  GD  Searle  and  Co.,  Chicago,  IL)  for  the  management  of  non-viable  first  trimester 
pregnancies.  Specifically,  Misoprostol  (15-S-15-methyl  PGE1)  will  be  compared  to  a  placebo  with 
expectant  management  in  who  have  documented  non-viable  gestations.  We  will  examine  the 
following  outcome  variables:  time  to  resolution,  number  of  patients  requiring  dilation  and 
curettage,  change  in  hematocrit,  cost  to  the  institution,  patient  satisfaction,  and  reported  side 
effects. 

Technical  Approach:  Patients  presenting  to  the  OB/GYN  clinic  with  a  nonviable  gestation, 
diagnosis  documented  by  endovaginal  ultrasound  will  be  enrolled.  Ultrasonic  findings  will  be 
verified  by  two  of  the  resident  staff  from  the  obstetrics  and  gynecology  department  of  Madigan 
Army  Medical  Center.  Patients  consenting  will  be  directed  to  the  OB/GYN  clinic  for  evaluation, 
exam,  and  counseling  and  to  watch  the  video  giving  explanation  of  purpose  of  the  study  and  the 
planned  procedure,  but  also  expected  side  effects  and  possible  complications.  Patients  will  be 
randomized  into  two  groups:  study  group  receiving  Misoprostol  per  vagina  and  the  control  group 
receiving  a  placebo  per  vagina.  Subjects  will  be  issued  an  envelope  and  go  to  the  pharmacy  to  pick 
up  their  study  medication,  blinded  to  them  and  the  provider.  They  will  also  be  given  Motrin  and 
Phenergan  to  help  alleviate  undesired  side  effects.  Four  200  ug  tablets  of  Misoprostol  or  placebo 
will  be  placed  in  the  posterior  fornix  of  the  vagina  using  a  speculum  under  the  direct  visualization 
of  the  provider.  Patients  will  return  in  24  hours  for  re-examination.  If  no  evidence  of  an 
intrauterine  pregnancy  remains,  patients  will  be  informed  that  their  miscarriage  was  complete, 
given  precautions  and  asked  to  make  an  appointment  for  follow-up  in  4  weeks  in  addition  to 
weekly  visits  to  the  lab  for  quantitative  BHCG.  All  patients  will  be  followed  until  the  quantitative 
BHCG  has  fallen  zero  to  ensure  resolution  of  the  pregnancy  event. 

Patients  with  evidence  of  a  gestational  sac  will  be  given  a  second  dose  of  Misoprostol  or  a  D&C  if 
they  choose  to  withdraw  from  the  study  or  a  surgical  intervention  if  it  is  deemed  clinically 
indicated  by  the  attending  staff.  Again,  subjects  will  be  given  appropriate  counseling  and 
precautions  and  asked  to  follow  up  in  an  additional  24  hours  for  re-evaluation.  Surveys  will  be 
given  at  each  visit  and  follow  up  to  evaluate  patient  satisfaction  and  also  to  query  for  unintended 
side  effects  and  complications. 

Progress:  This  protocol  completed  enrollment  during  FY06,  with  thirty  patients  enrolled,  five 
during  the  last  12  months.  Data  analysis  has  been  conducted  and  results  scheduled  for 
presentation  at  an  upcoming  AFD  meeting  in  October  2006. 


266 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204111 

Status:  Ongoing 

Title:  Glyburide  Compared  to  Insulin  in  the  Management  of  White's 
Gestational  Diabetes 

Classification  A2 

Principal  Investigator:  MAJ  Demetrice  L.  Hill,  MC 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Andrea  D.  Shields,  MC;  LTC  Damian  J.  Paonessa,  MC,  USAF; 
MAJ  Jennifer  L.  Gotkin,  MC;  LTC  Bobby  C.  Howard,  MC,  USAF;  LTC  Peter  G.  Napolitano,  MC; 
COL  Peter  E.  Nielsen,  MC;  CPT  Shannon  K.  Flood,  MC 

Start  -  Completion:  Funding: 

12/14/2004  -  Mar  2006  Tripler  AMC  via  MIPR 

Periodic  Review: 

8/22/2005 

Study  Objective:  Pregnant  women  who  meet  the  diagnostic  criteria  for  gestational  diabetes  and 
fail  dietary  control  will  be  randomized  into  two  groups.  One  group  will  be  prescribed  glybride  and 
the  other  insulin  in  order  to  achieve  optimal  glucose  control  in  pregnancy  as  manifested  by 
decreased  incidence  of  large  for  gestational  age  fetuses. 

Technical  Approach:  This  study  will  randomize  100  pregnant  women  into  two  groups,  Group  1 
will  be  prescribed  glyburide  and  Group  2  will  be  prescribed  insulin  in  order  to  achieve  optimal 
glucose  control  in  pregnancy  as  manifested  by  decreased  incidence  of  large  for  gestational  age 
fetuses.  Subjects  randomized  into  standard  therapy  insulin  arm  will  have  their  insulin  dose 
calculated  by  established  standards.  Insulin  will  be  adjusted  on  a  weekly  basis  in  order  to 
maintain  optimal  glucose  control.  Women  assigned  to  receive  glyburide  will  begin  with  2.5  mg 
orally  with  the  morning  meal.  Glyburide  dosage  will  be  increased  weekly  as  indicated  by  the  above 
threshold  values  to  a  maximum  daily  dose  of  20  mg  to  achieve  glucose  control.  If  maximum  daily 
dose  of  glyburide  does  not  result  in  reaching  the  threshold  values,  patients  will  be  administered 
insulin;  however,  data  will  be  analyzed  on  an  intent-to-treat  basis.  Continuous  variables  will  be 
presented  as  mean  +/-  standard  deviation,  ordinal  variables  as  medians,  and  dichotomous  as 
percentages.  Continuous  data  with  normal  distribution  will  be  analyzed  using  unpaired  (2sample) 
t-test.  For  more  than  2  samples,  analysis  of  variance  (ANOVA,  with  possible  repeated  measures) 
will  be  used  to  analyze  differences  in  outcome.  Non-parametric  equivalent  tests  will  be  used  to 
compare  ordinal  variables  or  continuous  variables  not  normally  distributed.  Categorical  variables 
will  be  compared  with  the  chi-square  or  Fisher  exact  test.  Odds  ratios  will  be  calculated,  with  95% 
confidence  intervals.  Logistic  regression  may  be  needed  to  adjust  for  confounding  variables. 

Progress:  This  protocol  was  closed  to  enrollment  at  MAMC  due  to  difficulties  with  recruitment 
(many  potential  candidates  were  beyond  the  34  week  time  of  diagnosis)  and  low  enrollment.  Eight 
patients  were  enrolled;  three  were  randomized  to  Glyburide  and  five  to  insulin.  No  patients  on 
Glyburide  had  adverse  reactions;  however,  two  failed  Glyburide  treatment  and  were  switched  to 
insulin.  This  protocol  will  remain  ongoing  at  MAMC  until  the  protocol  is  completed  at  TAMC. 


267 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206099  Status:  Ongoing 

Title:  Molecular  mechanisms  of  progesterone  mediated  inhibition  of  LPS  and  other 

inflammatory  agent  induced  production  of  pro-inflammatory  cytokines  in  the  fetal-maternal 

circuitry  of  the  human  placenta 

Principal  Investigator:  MAJ  Demetrice  L.  Hill,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Damian  J.  Paonessa,  MC,  USAF;  MAJ  Jennifer  L.  Gotkin,  MC; 

CPT  Jeremy  P.  Celver,  MS;  Heidi  M.  Cederholm,  B.S.;  James  R.  Wright,  BA,  MT  (ASCP);  LTC 

Peter  G.  Napolitano,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/16/2006  -  Apr  2007  DCI  N/A 

Study  Objective:  To  identify  the  molecular  mechanisms  by  which  progesterone  modulates  pro 
inflammatory  cytokine  production  following  LPS  and  other  inflammatory  agent  treatment  of  cells 
and  tissue  within  the  fetal/maternal  circuit  of  the  human  placenta.  Analysis  will  include  ELISA, 
immunocytochemistry,  western,  antibody  array,  and  high  throughput  proteomics. 

Technical  Approach:  Placentas  from  normal  women  undergoing  elective  cesarean  delivery  prior 
to  the  onset  of  labor  will  be  obtained  within  15  minutes  of  delivery.  At  the  time  of  cord  clamping, 
20cc  of  fetal  cord  blood  will  be  obtained,  spun  down  and  the  white  blood  cells  collected  and  exposed 
to  50mg/ml  lipopolysaccharide  and  evaluated  using  ID  or  2D  gel  electrophoresis.  Additionally, 
both  umbilical  arteries  will  be  gently  and  thoroughly  flushed  with  Dulbecco's  modified  Eagle's 
medium  (Gibco,  Grand  Island,  NY)  until  the  chorionic  plate  placental  arteries  are  grossly  free  of 
blood.  The  arteries  will  be  dissected  from  the  placenta,  carefully  separating  connective  tissue  from 
the  endothelium.  Eight  contiguous  segments  of  the  umbilical  artery  (approximately  5  mm  each) 
will  be  weighed  and  cultured  in  6-well  dishes  (four  per  well)  in  either  Hanks  Balanced  Salt 
Solution  (HBSS)  or  Dulbecco's  Modified  Eagle's  medium  with  Ham's  F12  nutrient  mixture  (1:1) 
(DMEM/F12),  antibiotics  and  2  mmol/L  glutamine  in  5%  carbon  dioxide  at  37C.  Samples  will  be 
treated  with  50ng/mL  of  lipopolysaccharide,  lipopolysaccharide  and  medroxyprogesterone  acetate 
(MPA)  (50  ng/50  ng/ml),  and  MPA  alone  (50  ng/ml).  Samples  will  be  screened  for  total  protein 
concentration  by  BCA  analysis  and  specific  induction  of  the  inflammatory  response  by  LPS  will  be 
verified  with  an  116  or  IL10  assay.  Two  placental  explants  from  each  group  will  be  snap-frozen  in 
liquid  nitrogen  and  stored  at  -130C  for  possible  total  cellular  proteomic  analysis  at  a  later  date. 
The  remaining  placental  explants  will  be  stored  in  formalin  at  4C  and  sectioned  for 
immunohistochemical  analyses  as  necessary. 

Total  protein  from  equal  volumes  of  supernatant  will  be  separated  by  ID  or  2D  gel  electrophoresis 
with  the  assistance  of  Dr  Robert  Allen,  PhD.  Separated  proteins  will  be  labeled  in  gel  by 
coomassie  blue  and  silver  staining.  MALDI-TOF  (40.00/protein)  will  be  used  to  identify  proteins 
with  dissimilar  expression  patterns  (e.g.,  a  consistent  change  between  LPS  and  control  in  2/3  of 
the  tested  samples).  Immunohistochemistry,  western  analysis  of  2D  gels  with  commercially  - 
available  antibodies  and  ELISA  analysis  will  validate  the  proteomic  analyses  when  feasible.  A 
SELDI-based  proteomic  analysis  will  also  be  considered  depending  on  the  effectiveness  of  the  gel 
electrophoresis. 

Progress:  Ten  samples  have  been  evaluated.  Large  variations  in  the  IL-6  production  in  response 
to  LPS  and  LTA  have  been  found.  Factors  are  believed  to  be  technician  related.  The  protocol 
continues  to  collect  samples  and  refine  scientific  techniques. 


268 


Detail  Summary  Sheet 

Date:  30  Sep  06 

Number:  203067 

Status:  Ongoing 

Title:  The  Effects  of  IL-10  on  the  Production  of  Inflammatory  Cytokine: 
Explant  Model 

s  in  a  Placental  Artery 

Principal  Investigator:  LTC  Bobby  C.  Howard,  MC,  USAF 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Andrea  D.  Shields,  MC;  MAJ  Christine  M.  Kovac,  MC;  LTC 
Peter  G.  Napolitano,  MC 

Start  -  Completion: 

4/30/2003  -  Jun  2003 

Funding: 

Air  Force  via  MIPR 

Periodic  Review: 

4/20/2006 

Study  Objective:  To  determine  the  effects  of  IL-10  on  placental  artery  production  of 
inflammatory  cytokines  from  normal  patients. 


Technical  Approach:  Maternal-fetal  inflammatory  states  are  associated  with  preterm  labor, 
preterm  premature  rupture  of  membranes,  preeclampsia,  fetal  growth  restriction  and  fetal  demise 
It  is  also  believed  that  cerebral  palsy  results  from  a  fetal  inflammatory  response  characterized  by 
an  environment  of  pro-inflammatory  cytokines.  IL-10  is  a  potent  anti-inflammatory  cytokine  that 
has  a  potential  role  in  the  treatment  of  clinical  septicemia  by  down-regulating  the  production  of 
pro-inflammatory  cytokines.  Approximately  4  specimens  will  be  studied  here  at  MAMC. 

Progress:  This  protocol  has  not  yet  initiated  enrollment,  pending  preliminary  data  from  another 
study  that  is  currently  in  data  analysis.  Modifications  may  be  required  prior  to  initiating 
enrollment. 


269 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203066  Status:  Ongoing 

Title:  The  Production  of  Immunoregulatory  Cytokines  in  a  Placental  Artery  Explant  Model 
Principal  Investigator:  LTC  Bobby  C.  Howard,  MC,  USAF 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Andrea  D.  Shields,  MC;  MAJ  Christine  M.  Kovac,  MC;  LTC 
Peter  G.  Napolitano,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

4/30/2003  -  Jun  2003  Air  Force  via  MIPR  4/20/2006 

Study  Objective:  To  determine  the  production  of  inflammatory  cytokines  from  the  placenta 
vessels  of  normal  patients  following  endotoxin  stimulation. 

Technical  Approach:  Levels  of  two  distinct  cytokines,  IL-6  and  IL-10  will  be  determined.  IL-6  is 
a  Th-1  type  cytokine  that  is  implicated  in  cell-mediated  damage  in  clinical  states  characterized  by 
an  inflammatory  response.  In  contrast,  IL-10  is  a  responsible  for  down-regulating  the  TH-1  like 
response  and  has  been  demonstrated  to  inhibit  the  damage  related  to  inflammatory  states.  By 
understanding  the  production  rate  of  these  cytokines  by  placental  arteries  at  baseline  and  under 
stimulated  conditions,  it  will  enable  us  to  study  the  potential  therapeutic  modalities  to  suppress 
the  production  of  inflammatory  cytokines.  Approximately  4  specimens  will  be  examined  here  at 
MAMC. 

Progress:  This  protocol  has  completed  specimen  collection  with  a  total  of  eleven  patients 
consented  in  this  study.  Data  analysis  is  currently  ongoing. 


270 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204088 

Status:  Ongoing 

Title:  Use  of  Transvaginal  Cervical  Length  Measurements  in 

Principal  Investigator:  LTC  Bobby  C.  Howard,  MC,  USAF 

Twin  Gestations 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  LTC  Peter  G.  Napolitano,  MC;  Samantha  J.  Thomas,  RN 

Start  -  Completion:  Funding: 

9/17/2004  -  May  2006  DCI 

Periodic  Review: 

5/23/2006 

Study  Objective:  To  determine  if  the  use  of  routine  transvaginal  cervical  length  ultrasound  can 
be  used  to  prevent  preterm  deliveries  in  twin  gestations. 


Technical  Approach:  Twin  gestations  are  one  of  the  highest  risk  populations  for  preterm  labor 
and  ideal  to  use  in  this  prospective  randomized  clinical  trial  to  determine  if  the  use  of  transvaginal 
cervical  length  measures  can  be  used  to  improve  perinatal  outcome  and  prevent  unneeded 
intervention  in  women  destined  to  deliver  at  term.  Subjects  will  be  randomized  to  either  routine 
management  or  serial  transvaginal  ultrasound  assessments  of  cervical  length.  Subjects 
randomized  to  cervical  length  assessment  will  be  managed  according  to  a  set  protocol  based  on 
cervical  length.  Potential  management  options  will  include  expectant  management,  activity 
restriction,  frequent  nursing  contact,  and/or  offering  cerclage  placement.  The  primary  outcome 
analysis  will  compare  gestational  age  at  delivery  between  groups. 

Progress:  This  protocol  closed  to  enrollment  in  May  2006,  with  seven  patients  enrolled  at  MAMC, 
one  during  FY06.  Data  analysis  is  ongoing. 


271 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205005  Status:  Ongoing 

Title:  The  Distribution  of  Bishop  Scores  and  Quantitative  Values  of  Fetal  Fibronectin  (fFN)  in 

Nulliparous  Patients  Between  37-42  Weeks  Gestation:  A  Prospective  Observational  Study 

Principal  Investigator:  CPT  Alison  L.  Lattu,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Bobby  C.  Howard,  MC,  USAF;  LTC  Peter  G.  Napolitano,  MC; 

COL  Peter  E.  Nielsen,  MC;  MAJ  Shad  H.  Deering,  MC;  Kathleen  T.  Gardner,  RN 

Start  -  Completion:  Funding:  Periodic  Review: 

3/11/2005  -  Feb  2006  Adeza  Biomedical  Corp  via  Geneva  Foundation  9/29/2006 

Study  Objective:  To  evaluate  the  distribution  of  Bishop  scores  and  quantitative  values  of  fetal 
fibronectin  (fFN)  in  nulliparous  patients  between  the  ages  18  -  40  and  between  37  weeks  through 
42  weeks  gestation.  The  secondary  objective  is  to  estimate  the  predictive  value  of  Bishop  scores 
and  fetal  fibronectin  (fFN)  testing  in  predicting  delivery  outcome  (e.g.  vaginal  or  cesarean  delivery) 
in  nulliparous  patients  between  37  weeks  through  42  weeks  gestation.  The  third  objective  is  to 
compare  the  concordance  and  statistical  agreement  between  matched  fFN  test  results  collected 
with  a  speculum  and  fFN  tests  results  collected  without  a  speculum.  In  this  pilot  study  sample 
size  is  not  necessarily  sufficient  for  conclusive  results. 

Technical  Approach:  This  is  a  prospective  observational  clinical  study  in  women  between  the 
ages  of  18  through  40.  Between  37  weeks  through  42  weeks  gestation  and  following  verification  of 
inclusion  criteria,  fFN  testing  of  cervicovaginal  specimen  obtained  from  the  lower  one-third  of  the 
vagina,  fFN  testing  of  a  cervicovaginal  specimen  obtained  with  a  speculum  and  digital  cervical 
exam  for  the  evaluation  of  Bishop  score  at  the  time  of  their  routine  prenatal  visit.  All  patients 
meeting  inclusion  criteria  and  who  consent  to  participation  will  have  the  following  information 
recorded:  patient's  age,  gestational  age,  dating  criteria,  presentation  (and  how  this  was  assessed), 
fetal  fibronectin  test  results,  Bishop  score  (specifically,  cervical  dilation,  effacement,  station, 
position,  and  consistency),  and  whether  or  not  membrane  sweeping  was  performed.  Information 
will  be  obtained  regarding  the  most  recent  time  of  intercourse  and  cervical  exam.  Following 
delivery,  the  following  information  about  the  patient  will  be  obtained:  gestational  age  at  time  of 
admission  for  delivery,  Bishop  score  (cervical  dilation,  station,  effacement,  position,  and 
consistency)  at  time  of  admission,  indication  for  admission,  whether  labor  onset  was  spontaneous, 
induced,  or  augmented,  length  of  hospital  stay,  time  from  admission  to  delivery,  mode  of  delivery 
and  birth  weight.  Additionally,  data  regarding  the  presence  of  the  following  maternal  and  fetal 
complications  will  be  collected:  fetal  macrosomia  (birth  weight  >4000gm),  pre-eclampsia, 
chorioamnionitis,  endomyometritis,  meconium  stained  amniotic  fluid,  NICU  admission,  and 
intrauterine  fetal  death. 

Progress:  This  protocol  remains  open  to  enrollment  with  135  patients  enrolled  to  date;  115 
patients  received  diagnostic  testing,  fourteen  were  not  tested/lost  to  follow  up,  three  delivered 
before  testing  began,  and  three  withdrew  consent.  Investigators  are  currently  analyzing  interim 
data  but  plan  to  continue  the  protocol  until  full  enrollment  has  been  reached.  Plan  to  present  some 
of  the  interval  data  at  the  annual  American  College  of  OB/Gyn  Clinical  Meeting  in  May. 


272 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203078  Status:  Ongoing 

Title:  Use  of  Pipelle  Endometrial  Sampling  in  the  Evaluation  of  Abnormal  First  Trimester 
Pregnancy 

Principal  Investigator:  CPT  Alison  L.  Lattu,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  Gregory  E.  Chow,  MD;  LTC  Michael  K.  Chinn,  MC;  CPT  Harlan  I. 
Rumjahn,  MC;  CPT  Joren  B.  Keylock,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/27/2003  -  Sep  2004  DCI  5/10/2006 

Study  Objective:  To  evaluate  the  sensitivity  of  endometrial  sampling  in  the  detection  of 
intrauterine  products  of  conception  in  abnormal  gestations. 

Technical  Approach:  This  study  will  look  at  patients  undergoing  evaluation  and  management 
for  abnormal  gestations  who  have  opted  for  surgical  management  with  dilation  and  cutterage 
(D&C).  This  will  not  include  patients  undergoing  emergency  procedures.  Approximately  100 
patients  will  be  enrolled  into  this  study  here  at  MAMC.  The  patient  will  have  a  pipelle 
endometrial  sampling  performed  prior  to  the  D&C.  This  procedure  consists  of  a  pipelle  being 
inserted  in  to  the  uterine  fundus  and  drawing  it  back  and  forth  for  15-30  seconds  to  obtain  a 
sample  of  the  endometrial  tissue  and  uterine  contents.  This  sample  will  be  transferred  to  a  10% 
formalin  solution  and  then  taken  to  the  pathology  department  at  MAMC  for  processing  and 
evaluation. 

Progress:  Interim  data  analysis  has  been  completed  with  sensitivity  of  EMBX  73%  and  92%  for 
curettage.  No  adverse  outcomes.  Investigators  will  consider  whether  or  not  to  proceed  with 
continued  enrollment. 


273 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205089  Status:  Ongoing 

Title:  Pilot  Study  of  a  Novel  Cord  Blood  Collection  Technique 
Principal  Investigator:  CPT  Megan  M.  Manshande,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Jasmine  T.  Daniels,  MC;  LTC  David  E.  McCune,  MC;  LTC 
Peter  G.  Napolitano,  MC;  COL  Jerome  B.  Myers,  MC;  CPT  Mitchel  T.  Holm,  MC;  CPT  Jeremy  P. 
Celver,  MS;  Carol  D.  Dean,  RN,  BSN 

Start  -  Completion:  Funding:  Periodic  Review: 

5/26/2005  -  Apr  2006  DCI  5/22/2006 

Study  Objective:  Primary  Objective:  To  demonstrate  the  feasibility  of  a  novel  technique  for 
umbilical  cord  blood  collection  after  delivery.  Secondary  Objective:  To  compare  this  method  of 
collection  to  historical  results  obtained  from  medical  literature. 

Technical  Approach:  After  collecting  umbilical  cord  blood  via  the  method  proposed  in  this 
protocol,  investigators  will  compare  blood  volumes  and  the  number  of  hematopoietic  progenitor 
cells  harvested  to  historical  controls.  Investigators  propose  that  this  new  method  of  cord  blood 
collection  after  delivery  will  allow  collection  of  a  larger  volume  of  umbilical  cord  blood  than  the 
currently  used  standard  method  of  cord  blood  collection  thus  allowing  harvest  of  a  larger  number 
of  stem  cells.  Development  of  a  collection  technique  which  would  give  a  higher  yield  of  stem  cells 
would  broaden  the  range  of  transplant  options  available  for  adult  recipients. 

Progress:  Investigators  have  now  obtained  the  proper  equipment  kits  to  collect  samples  and  will 
have  all  samples  collected  within  the  next  two  months.  Two  patients  were  enrolled  in  the  study 
since  its  approval,  but  will  not  be  included  in  the  final  data  because  investigators  were  perfecting 
the  collection  technique  prior  to  actually  collecting  samples  to  include  in  the  study. 


274 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203045  Status:  Ongoing 

Title:  Randomized  Controlled  Trial  of  Endurance  Exercise  and  Gallbladder  Disease  Risk  in 

Overweight  Pregnant  Women 

Principal  Investigator:  ETC  Peter  G.  Napolitano,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  Sum  P.  Lee,  M.D.,  Ph.D;  Shirley  Beresford,  Ph.D;  Cynthia  Ko, 

M.D.;  Anne  McTiernan,  M.D.;  Deborah  J.  Bowen,  Ph.D;  LTC  James  K.  Howden,  MC;  COL  Peter 

E.  Nielsen,  MC;  Scott  J.  Schulte,  M.D.;  Mary  Emond,  Ph.D 

Start  -  Completion:  Funding:  Periodic  Review: 

1/27/2004  -  Jan  2008  UW  via  The  Geneva  Foundation  1/24/2006 

Study  Objective:  (1)  To  evaluate  whether  an  endurance  exercise  program  is  associated  with 
lower  risk  of  gallbladder  disease  in  overweight  pregnant  women.  (2)  To  evaluate  whether  an 
endurance  exercise  intervention  program  changes  leptin  levels  in  pregnancy  among  overweight 
women.  (3)  To  use  statistical  methods  to  examine  the  associations  between  gallbladder  disease 
incidence  and  potential  causal  variables  in  this  prospective  trial.  These  variables  include  baseline 
levels  of  leptin,  HDL,  insulin  levels,  BMI  (as  it  varies  within  women  classified  as  overweight)  and 
changes  in  these  variables.  Secondarily,  we  aim  to  estimate  the  degree  of  compliance  and  overall 
adherence  to  an  exercise  intervention  in  normal  weight  pregnant  women,  in  the  context  of  a 
randomized  intervention  study. 

Technical  Approach:  This  trial  will  evaluate  the  effect  of  an  intervention  designed  to  increase 
regular  endurance  exercise  of  moderate  to  vigorous  intensity  on  the  risk  of  gallbladder  disease  in 
pregnancy..  Women  will  be  stratified  according  to  overweight  or  normal  weight  status.  The 
randomized  controlled  trial  will  be  confined  to  the  former  group  (n=862),  while  a  feasibility  trial 
will  be  conducted  among  250  normal  weight  women.  The  comparison  groups  will  receive  the 
exercise  intervention  in  the  post-partum  period.  They  will  continue  their  usual  activities  during 
pregnancy.  Thus  all  women  participating  in  the  trial  will  receive  the  benefit  of  exercise  training  at 
some  point  during  the  study  period.  The  study  population  will  be  pregnant  women  aged  18  to  45. 
All  women  presenting  for  prenatal  care  will  be  potentially  eligible.  Additional  clinical  procedures 
specific  to  the  study  include  a  first  and  third  trimester  ultrasound  of  both  the  gallbladder  and  the 
fetus,  and  an  additional  blood  draw  at  those  times.  Usual  care  includes  a  second  trimester 
ultrasound  of  the  fetus,  to  which  will  be  added  an  ultrasound  of  the  gallbladder,  and  a  blood  draw, 
to  which  additional  tubes  will  be  added.  To  enhance  cooperation  with  additional  study  procedures 
in  the  exercise  intervention  study,  we  will  provide  a  $30  financial  incentive  for  completing  the  1st 
trimester  and  late  3rd  trimester  blood  draws.  This  incentive  will  not  be  provided  for  the  early  3rd 
trimester  blood  draw,  since  it  occurs  at  the  same  time  as  a  routine  prenatal  blood  draw.  As  an 
added  incentive  to  participate,  an  additional  scan  of  the  fetus  will  be  made  at  the  first  trimester 
gallbladder  ultrasound  examination.  This  will  allow  women  an  early  glimpse  of  their  baby.  For 
women  who  have  other  children,  we  will  provide  a  reimbursement  for  childcare  expenses  ($3  per 
hour)  during  exercise  or  stretching  classes.  Pedometers  will  be  provided  during  the  study  for  the 
intervention  group,  and  at  the  postpartum  visit  for  the  control  women. 

Progress:  This  protocol  remains  open  to  enrollment,  with  3,707  women  contacted,  846  women  who 
agreed  to  enroll  and  443  who  completed  the  study.  Of  this  group,  204  were  disqualified  because  of 
gallstones,  miscarriage  or  failure  to  comply  with  study  requirements/medical  conditions. 

Expanding  the  BMI  range  to  34.9  has  allowed  enrollment  of  38  additional  women  that  would  not  of 
qualified. 


275 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203001 

Status:  Ongoing 

Title:  The  Effect  of  Magnesium  on  Matrix  Metalloproteinase-9  Activity  in 
at  Delivery  of  Pregnancies  Complicated  by  Chorioamnionitis 

Umbilical  Cord  Blood 

Principal  Investigator:  ETC  Peter  G.  Napolitano,  MC 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Patrick  M.  McNutt,  MS;  Lisa  M.  Pierce,  D.Sc.;  MAJ  Christine 

M.  Kovac,  MC;  LTC  Bobby  C.  Howard,  MC,  USAF;  MAJ  Brian  T.  Pierce,  MC;  LTC  Nathan  J. 
Hoeldtke,  MC 

Start  -  Completion:  Funding: 

7/29/0030  -  Dec  2002  DCI 

Periodic  Review: 

9/21/2006 

Study  Objective:  To  determine  baseline  umbilical  cord  serum  levels  of  matrix  metalloproteinase- 
9  levels  at  delivery  in  pregnancies  where  labor  is  complicated  by  chorioamnionitis  compared  to 
normal  term  controls.  To  determine  if  magnesium  will  reduce  the  enzymatic  activity  of  serum 
matrix  metalloproteinase-9  in  the  umbilical  cord  plasma  of  neonates  from  pregnancies  complicated 
by  chorioamnionitis  compared  to  normal  controls. 

Technical  Approach:  Matrix  metalloproteinases  are  zinc-dependent  enzymes  and  it  is  possible 
that  ionized  magnesium  which  easily  crosses  the  placenta  could  competitively  inhibit  MMP-9 
enzyme  by  displacing  zinc.  We  propose  to  test  this  hypothesis  by  first  determining  what  normal 
levels  of  MMP-9  enzyme  are  in  pregnancies  complicated  by  infection  (those  complicated  by 
chorioamnionitis  in  labor)  compared  to  normal  pregnancies  with  normal  labors.  Since  it  would  not 
ethically  be  acceptable  to  administer  Magnesium  sulfate  a  tocolytic  to  such  complicated 
pregnancies,  we  will  collect  the  plasma  of  such  pregnancies  then  expose  it  ex  vivo  to  similar  levels 
of  magnesium  that  would  be  expected  if  we  had  treated  the  mother  with  standard  therapy.  Then 
assay  those  samples  for  MMP-9  enzyme  activity. 

Progress:  Bench  top  research  completed,  paper  submitted  but  rejected,  and  awaiting  changes  to 
be  made  and  resubmission.  This  study  remains  open  as  investigators  may  need  to  collect  more 
specimens,  based  on  peer  review  of  findings. 


276 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203099 

Status:  Ongoing 

Title:  Umbilical  Cord  Plasma  Homocysteine  Concentrations  at  Delivery  in  Pregnancies 
Complicated  by  Preeclampsia 

Principal  Investigator:  ETC  Peter  G.  Napolitano,  MC 

Department:  OB/GYN 

Facility:  MAMC 

Associate  Investigator(s):  CPT  Christopher  S.  Murphy,  MC; 

CPT  Charles  L.  Wakefield,  MC 

Start  -  Completion:  Funding: 

8/1/2003  -  Dec  2003  DCI 

Periodic  Review: 

6/20/2006 

Study  Objective:  The  purpose  of  this  study  is  to  evaluate  the  level  of  umbilical  cord  plasma 
homocysteine  in  gestations  complicated  by  pre-eclampsia  compared  to  normotensive  gestations. 


Technical  Approach:  General  Protocol  Sampling  Umbilical  cord  blood  samples  will  be  obtained 
immediately  after  cord  clamping  by  direct  venipuncture  of  the  umbilical  vein  collected  in  lavender 
top  tubes.  The  specimens  will  be  stored  on  ice  and  centrifuged  at  3000  rpm  for  15  min  as  soon  as 
possible.  After  extracting  the  serum  plasma,  it  will  be  divided  into  several  aliquots  for  storage.  All 
specimens  will  be  frozen  and  maintained  at  -70o  C.  Maternal  plasma  obtained  at  the  time  of 
routine  labor  admission  blood  work  will  be  collected  and  stored  in  a  similar  fashion.  At  four  points 
during  the  study,  the  specimens  will  be  collected  and  sent  to  William  Beaumont  Army  Medical 
Center,  TX,  Dept  of  Pathology  for  homocysteine  level  analysis.  A  sample  of  lmL  of  EDTA  plasma 
is  necessary  for  laboratory  analysis.  The  plasma  homocysteine  level  is  measured  by  AD  VIA 
Centaur  HCY  assay.  Each  specimen  will  be  run  in  duplicate. 

Progress:  This  protocol  remains  open  to  enrollment.  No  new  patients  were  enrolled  since  the  last 
progress  report.  The  protocol  was  amended  to  allow  inclusion  of  patients  with  Preterm 
preeclampsia  and  Preterm  preeclampsia  with  IUGR,  although  recruitment  of  patients  did  not 
occur.  Recruitment  and  enrollment  is  expected  to  begin  with  the  addition  of  a  new  associate 
investigator,  Dr  Christopher  Murphy.  At  this  time,  data  analysis  has  been  performed  on  ten 
control  patients  and  eight  patients  with  pre-eclampsia.  There  was  a  significant  difference  between 
HCY  levels  in  the  pregnancies  complicated  by  pre-eclampsia  and  the  control  patients  (maternal 
and  fetal). 


277 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204108  Status:  Completed 

Title:  The  Effects  of  Cholic  Acid  and  Deoxycholic  Acid  on  Placental  Artery  Perfusion  Pressures 
in  the  Ex  Vivo  Placental  Cotyledon  Model 

Principal  Investigator:  ETC  Damian  J.  Paonessa,  MC,  USAF 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Nathan  J.  Hoeldtke,  MC;  LTC  Peter  G.  Napolitano,  MC;  LTC 
Bobby  C.  Howard,  MC,  USAF;  MAJ  Andrea  D.  Shields,  MC;  MAJ  Jennifer  L.  Gotkin,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/31/2004  -  May  2005  Air  Force  via  MIPR  8/22/2005 

Study  Objective:  To  determine  if  infused  concentrations  of  cholic  acid  and  deoxycholic  acid  affect 
placental  artery  perfusion  pressures. 

Technical  Approach:  This  bench  study  will  evaluate  the  placental  vascular  tone  after  exposure 
to  the  bile  salts  cholic  acid  and  deoxycholic  acid.  Placentas  from  normal  women  will  be  obtained 
within  15  minutes  of  delivery.  Fetal  surface  will  be  inspected  for  a  chorionic  artery  and  vein  pair 
supplying  a  functional  cotyledon.  Although  wavier  of  informed  consent  was  appropriate, 
investigators  chose  to  utilize  a  consent  form  to  obtain  permission  for  use  placentas  under  this 
bench  research  protocol. 

Progress:  The  PI  reported  this  protocol  completed  in  June  2006;  he  is  in  the  process  of  data 
analysis.  Nine  placentas  were  collected;  three  did  not  survive  the  attempt  to  collect  data. 


278 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205021  Status:  Ongoing 

Title:  Correlation  of  Persistent  Anal  Sphincter  Defects  and  Symptoms  following  Repair  of  Anal 

Sphincter  Lacerations  due  to  Obstetric  Injury  in  Primiparous  Women 

Principal  Investigator:  CPT  Christine  M.  Zalucki,  MC 

Department:  OB/GYN  Facility:  MAMC 

Associate  Investigator(s):  LTC  Jeffery  L.  Clemons,  MC;  CPT  Rhiana  D.  Saunders,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/10/2004  -  Jan  2005  DCI  11/21/2006 

Study  Objective:  To  identify  the  incidence  of  persistent  anal  sphincter  defects  following  repair  of 
anal  sphincter  lacerations  (ASL)  due  to  obstetric  injury  in  primiparous  women.  To  correlate  the 
size  of  the  persistent  anal  sphincter  defect  (ASD)  with  anal  incontinence  symptoms.  To  identify  the 
size  of  ASD  at  which  symptoms  increase  dramatically,  if  any.  To  identify  risk  factors  for 
symptomatic  ASD. 

Technical  Approach:  A  prospective  observational  study  will  be  conducted  over  a  24  month 
period.  Primiparous  women  that  have  sustained  an  ASL  and  undergone  successful  repair  will  be 
recruited  during  their  postpartum  stay  at  MAMC.  Obstetric  records  will  be  reviewed  to  collect 
demographic  data,  medical  history,  delivery  outcomes,  and  anal  sphincter  repair  technique.  At  8 
weeks  postpartum,  each  woman  will  undergo  endoanal  sonography  and  complete  the  Wexner  anal 
incontinence  questionnaire.  The  endoanal  ultrasound  will  be  used  to  detect  and  measure  the  size 
of  ASD.  A  persistent  ASD  will  be  defined  as  any  defect  of  the  integrity  of  the  IAS  or  EAS. 
Photographic  images  will  be  taken  of  the  largest  portion  of  the  ASD.  The  size  of  the  defect  (in 
degrees)  will  be  measured  by  a  protractor.  The  length  of  the  defect  (in  millimeters)  will  be 
measured  by  3-D  ultrasound.  Three  researchers  will  perform  all  measurements.  The 
endosonographer  will  be  blinded  to  the  questionnaire  results.  The  Wexner  anal  incontinence 
questionnaire  assesses  the  presence  and  frequency  of  incontinence  to  flatus,  liquid  and  solid  stool, 
pad  use,  and  lifestyle  alteration.  Scores  can  range  from  0  (complete  continence)  to  20  (severe 
incontinence  to  solid  stool  on  a  daily  basis).  A  score  of  4  or  more  at  2  months  post-partum  will 
define  a  symptomatic  ASD.  Women  with  and  without  symptomatic  ASD  will  be  compared  to 
identify  risk  factors  for  symptomatic  ASD.  Approximately  72  women  with  ASD  will  be  needed  to 
demonstrate  a  difference  in  defect  size  between  symptomatic  and  asymptomatic  ASD. 

Demographic  and  delivery  data  will  be  entered  onto  a  Data  Sheet.  The  ultrasound  data  and 
questionnaire  data  will  be  also  entered  onto  the  Data  Sheet.  All  data  will  then  be  transferred  to 
the  Excel  spreadsheet.  Security  issues  will  be  enforced  (locking  computer  and  office). 

Progress:  This  protocol  completed  the  enrollment  phase  with  a  total  of  47  patients  enrolled  at 
MAMC  over  the  20  month  enrollment  period.  Patients  will  continue  to  be  followed  by  phone 
through  FY07.  The  study  found  that  an  injury  to  the  internal  anal  sphincter  >  or  =  45  degrees  was 
strongly  associated  with  anal  incontinence  symptoms.  Also,  the  anal  sphincter  laceration  rate  at 
MAMC  is  3%,  and  persistent  defect  rate  is  79%.  No  risk  factors  were  identified  for  persistent  anal 
sphincter  defects.  One  patient  underwent  overlapping  sphincteroplasty  for  severe  anal 
incontinence. 


279 


Detail  Summary  Sheets 

Department  of  Pathology 


280 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203095  Status:  Terminated 

Title:  Implementation  of  the  SARS  Coronavirus  Real-Time  PCR  Primers  and  Probes  Assay  to 
Detect  SARS  Coronavirus  in  Respiratory  Specimens 

Principal  Investigator:  MAJ  Edward  P.  Ager,  MS 

Department:  Pathology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Steven  D.  Mahlen,  MS;  COL  Joseph  T.  Morris  III,  MC;  LTC 
David  K.  Turgeon,  MC;  LTC  James  E.  Cook,  MC;  CPT  Sheryl  A.  Bedno,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

5/12/2004  -  Jul  2004  CDC  via  MIPR  7/1/2005 

Study  Objective:  To  use  real-time  PCR  assays  to  detect  SARS  Coronavirus  RNA  in  respiratory 
specimens  and  as  a  surveillance  tool  allowing  public  health  laboratories  to  respond  to  the  outbreak 
and  limit  transmission  of  this  agent. 

Technical  Approach:  This  protocol  describes  a  plan  to  export  the  current  CDC  SARS 
Coronavirus  real-time  PCR  assay  to  participating  public  health  laboratories  and  clinical  diagnostic 
laboratories  within  the  Laboratory  Response  Network  (LRN)  for  use  in  diagnostic  evaluation  of 
SARS  Coronavirus  infection.  Fifty  patients  will  be  enrolled  for  this  protocol,  and  two  sets  of 
specimens  will  be  taken  from  each  subject.  One  set  of  specimens  will  be  shipped  to  the  CDC  for 
testing;  the  other  set  of  specimens  will  be  tested  for  the  SARS  Coronavirus  at  MAMC.  SARS 
Coronavirus  detection  data  will  be  collected  for  this  study,  and  compared  with  results  obtained 
from  the  CDC. 

Progress:  A  change  PI  was  approved  from  MAJ  Steven  Mahlen,  MS,  to  MAJ  Edward  Ager,  MS, 
Staff  Department  of  Pathology.  The  protocol  was  terminated  15  May  2006,  with  no  subjects 
enrolled.  No  human  infection  with  the  SARS  coronavirus  was  identified  in  over  2  years. 


281 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203041  Status:  Ongoing 

Title:  Use  of  a  Non-FDA  Approved  Gene  Amplification  Test  To  Detect  or  Rule-Out  Vaccinia  in 
Patients  With  Complications  Following  Smallpox  Vaccination  or  Possible  Contact  Vaccinia 

Principal  Investigator:  MAJ  Edward  P.  Ager,  MS 

Department:  Pathology  Facility:  MAMC 

Associate  Investigator(s):  MAJ  Steven  D.  Mahlen,  MS;  COL  Joseph  T.  Morris  III,  MC;  COL 
Mary  P.  Fairchok,  MC;  LTC  Peter  G.  Napolitano,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

4/30/2003  -  Mar  2004  DCI  7/20/2006 

Study  Objective:  To  determine  the  sensitivity,  specificity  and  clinical  utility  of  the  only  test 
currently  available  to  detect  vaccinia  virus  in  patients  who  may  be  experiencing  post-vaccination 
complications  following  smallpox  vaccination,  or  in  close  contacts  of  vaccinees  who  may  have  been 
inadvertently  inoculated  with  the  vaccinia  virus  (contact  vaccinia). 

Technical  Approach:  Clinicians  seeing  patients  with  possible  post-vaccination  complications  or 
suspected  contact  vaccinia  will  collect  and  submit  three  swabs  of  lesion  fluid  to  one  of  the  DOD 
Confirmatory  Labs  with  the  vaccinia  test.  One  swab  will  be  used  for  vaccinia  PCR  using  either  the 
Cepheid  SmartCycler  or  the  Idaho  Technology  LightCycler  platforms  that  are  approved  as  LRN 
tools.  DNA  extraction  and  amplification  will  be  done  strictly  following  the  LRN  protocol. 

Extraction  of  DNA  from  exudate  material  and  specimen  processing  will  take  approximately  2 
hours.  Amplification  results  will  be  final  approximately  30  minutes  after  the  amplification  begins. 
A  positive  amplification  result  is  determined  by  standardized  parameters  and  with  a  calculated 
threshold  done  by  the  real-time  PCR  unit.  The  second  swab  will  be  used  for  viral  culture.  Vaccinia 
virus  produces  cytopathic  effects  (CPE)  in  most  common  cell  lines  used  in  clinical  virology  labs. 

The  CPE  resemble  those  of  HSV,  CMV  and  adenovirus.  While  clinical  labs  can  rapidly  identify 
HSV,  adenovirus  and  CMV  in  infected  cell  lines  using  DFA,  there  is  no  such  test  for  vaccinia. 
However,  if  a  specimen  results  in  CPE,  but  is  negative  for  HSV,  adenovirus  and  CMV  by  DFA, 
then  that  culture  may  be  a  presumptive  result  for  vaccinia,  and  will  be  resulted  as  "CPE  from 
lesion  material  -  negative  for  HSV,  adenovirus,  and  CMV".  Specimens  with  no  resultant  CPE  will 
be  finalized  as  "No  virus  detected".  The  third  swab  will  be  submitted  for  bacterial  culture  and 
sensitivity  (standard  of  care).  Viral  and  bacterial  culture  data,  along  with  PCR  data  will  be  used 
in  conjunction  with  the  clinical  situation  to  help  determine  if  the  patient  has  post-vaccinial 
complications  due  to  vaccinia  virus,  contact  vaccinia,  or  is  experiencing  rashes  or  lesions  due  to 
other  causes.  All  specimens  kept  at  the  DOD  LRN  Confirmatory  Labs  will  be  handled  and 
disposed  of  in  accordance  with  federal  regulations. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  six  patients  enrolled,  one  during 
FY06.  This  is  a  CDC  Protocol  and  as  such  is  conducted  under  auspice  of  the  CDC  IRB. 


282 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205102  Status:  Ongoing 

Title:  Absolute  Lymphocytosis  in  Adults:  A  Laboratory  Protocol 
Principal  Investigator:  CPT  Jared  M.  Andrews,  MC 

Department:  Pathology  Facility:  MAMC 

Associate  Investigator(s):  CPT  Mitchel  T.  Holm,  MC;  COL  Jerome  B.  Myers,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/12/2005  -  Oct  2005  DCI  6/12/2006 

Study  Objective:  The  objective  is  to  analyze  and  report  correlations  between  diagnosis  rendered 
by  flow  cytometry  analysis  of  patients  with  peripheral  blood  lymphocytosis,  and  the  lymphocyte 
counts  and  other  demographics  of  the  patients.  International  guidelines  for  flow  cytometric 
analysis  of  peripheral  blood  lymphocytosis  to  rule  out  leukemia/  lymphoma  are  not  well  defined. 
These  correlations  can  be  used  to  help  develop  hospital  protocols  for  the  evaluation  of  absolute 
lymphocytosis  in  adults. 

Technical  Approach:  This  is  a  retrospective,  descriptive  study  of  Madigan  Army  Medical 
Center's  process  for  analysis  of  peripheral  blood  lymphocytosis  in  persons  greater  than  18  years  of 
age.  By  analyzing  the  demographic  data,  CBC,  and  flow  cytometrical  results  obtained,  it  is  our 
hypothesis  that  this  information  can  be  beneficial  in  more  accurately  defining  guidelines  for  the 
use  of  flow  cytometry  for  lymphocytosis,  and  promote  further  prospective  research  in  this  area. 

Progress:  This  protocol  has  completed  data  collection  and  statistical  analysis  and  remains 
ongoing  to  complete  final  manuscript  of  findings. 


283 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205042 

Status:  Ongoing 

Title:  Incidental  Anatomic  and  Histologic  Findings  in  Bariatric  Surgery  Specimens 

Principal  Investigator:  MAJ  Anne  L.  Champeaux,  MC 

Department:  Pathology 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  James  B.  Branch,  MC; 

CPT  Vance  Y.  Sohn,  MC 

Start  -  Completion:  Funding: 

2/14/2005  -  Apr  2005  DCI 

Periodic  Review: 

10/26/2006 

Study  Objective:  Collection,  review  and  compilation  of  anatomic/histologic  findings  in  bariatric 
surgery  specimens  processed  by  Madigan  Army  Medical  Center  (MAMC)  Department  of  Pathology, 
Anatomic  Pathology  Service  from  1994-2004. 


Technical  Approach:  Collection,  review  and  analysis  of  bariatric  surgery  specimen  reports 
generated  by  the  MAMC  Anatomic  Pathology  service  from  1994  through  2004  to  identify  and 
correlate  anatomic  and  histologic  findings  with  age  and  gender.  The  study  aims  to  elucidate  the 
range  of  anatomic  and  histologic  variables  found  in  partial  gastrectomy,  gallbladder  and 
appendices  removed  during  bariatric  procedures. 

Progress:  This  protocol  was  suspended  in  February  2006,  pending  completion  of  the  continuing 
review  process.  PI  intends  to  request  IRB  approval  to  increase  the  number  of  patient  cases  and 
records  up  to  600  and  add  an  associate  investigator. 


284 


Detail  Summary  Sheets 

Department  of  Pediatrics 


285 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203014  Status:  Terminated 

Title:  Clinical  Use  of  Reticulocyte  Hemoglobin  to  Detect  Iron  Deficiency  at  the  12  Month  Well 

Baby  Visit 

Principal  Investigator:  CPT  Rochelle  L.  Cason,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  CPT  Athena  J.  Stoyas,  MC;  LTC  Robert  G.  Irwin,  MC;  COL  Kelly  J. 

Faucette,  MC;  Elizabeth  N.  Hasert,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

3/4/2003  -  May  2003  DCI  9/28/2004 

Study  Objective:  To  determine  if  the  reticulocyte  hemoglobin  is  a  more  sensitive  and  specific 
marker  than  hemoglobin  and  hematocrit  for  iron  deficiency  at  the  12  month  well  child  visit. 

Technical  Approach:  This  is  a  prospective  study  that  will  evaluate  the  utility  of  reticulocyte 
hemoglobin  as  a  screen  for  iron  deficiency  and  iron  deficiency  anemia  in  comparison  to  current 
measures  of  hemoglobin  and  hematocrit.  All  infants  that  present  for  their  12  month  well  child 
check  and  any  infants  9  to  18  months  with  a  clinical  indication  or  who  have  missed  their  12  month 
well  baby  visit  will  have  screening  hemoglobin,  hematocrit,  and  reticulocyte  hemoglobin.  If  either 
hemoglobin,  hematocrit,  or  reticulocyte  hemoglobin  are  low  these  patient's  will  be  placed  on  iron 
therapy.  The  three  treatment  groups  will  include:  1.  Decreased  hemoglobin,  hematocrit,  and 
reticulocyte  hemoglobin;  2.  Decreased  hemoglobin  and/or  hematocrit.  Normal  reticulocyte 
hemoglobin;  3.  Normal  hemoglobin  and  hematocrit.  Decreased  reticulocyte  hemoglobin.  After  one 
month  of  therapy  a  repeat  venous  hemoglobin,  hematocrit,  and  reticulocyte  hemoglobin  will  be 
checked.  If  these  measurements  show  improvement  as  previously  defined,  the  patient  will  be 
diagnosed  with  iron  deficiency  and/or  iron  deficiency  anemia  and  will  continue  on  two  more 
months  of  iron  therapy.  Measurements  of  hemoglobin  and  hematocrit  and  reticulocyte  hemoglobin 
will  be  compared  in  their  sensitivity  and  specificity  in  detecting  iron  deficiency  and  iron  deficiency 
anemia.  If  group  1  shows  improvement  in  all  tested  variables,  this  would  suggest  that  reticulocyte 
hemoglobin  correlates  well  with  hemoglobin  and  hematocrit  measurements.  If  group  3  responds  to 
therapy  and  group  2  does  not  respond  to  therapy  this  would  indicate  that  reticulocyte  hemoglobin 
is  a  more  sensitive  and  specific  indicator  of  iron  deficiency.  60  patients  will  be  placed  into  each 
group.  Once  30  patients  are  in  each  group  an  interim  analysis,  using  chi  square,  of  the  data  will  be 
obtained  to  assess  if  there  is  statistical  significance. 

Progress:  The  IRB  terminated  this  protocol  in  August  2006,  when  no  principal  investigator  was 
assigned  by  the  Department  of  Pediatrics  during  the  study's  last  approval  period.  The  protocol  had 
been  suspended  at  the  request  of  associate  investigator,  Dr.  Hasert,  until  a  new  PI  could  be 
assigned.  The  last  report  noted  57  of  500  patients  enrolled  with  7  positive  results  that  support  the 
study  hypothesis. 


286 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204104 

Status:  Ongoing 

Title:  Health,  Quality  of  Life  &  Activity  in  Cerebral  Palsy 

Principal  Investigator:  COL  Beth  E.  Davis,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Robert  L.  Miller,  MC;  Kristie  Bjornson,  PhC,  PT 

Start  -  Completion:  Funding: 

9/13/2004  -  Jun  2006  United  Cerebral  Palsy  Research  &  Education 

Foundation  via  Grant 

Periodic  Review: 

8/10/2006 

Study  Objective:  Aim  1.  To  test  for  differences  in  activity  performance,  self  and  parent  reported 
health  status  and  QOL  (Quality  Of  Life)  among  youth  with  CP  (Cerebral  Palsy)  and  TDY 
(Typically  Developing  Youth)  by  level  of  activity  capacity,  while  controlling  for  baseline  activity 
performance  and  capacity,  age,  gender,  SES  and  current  day  outlook.  The  predicted  differences  in 
activity  performance,  self-reported  health  status  will  be  such  that  TDY  will  be  greater  than  CP 
youth  (TDY  >  CP),  and  that  these  differences  will  be  ordered  by  defined  levels  of  activity  capacity 
with  the  Gross  Motor  Function  Classification  System  (GMFCS)  such  that  TDY  >  Level  I  >  Level  II 
>  Level  III,  while  controlling  for  baseline  activity  performance,  age,  gender,  SES  and  current  day 
outlook.  The  predicted  differences  in  QOL  will  not  be  ordered  by  activity  capacity. 

Aim  2.  To  examine  the  associations  between  activity  level  (performance)  and  self  and  parent 
perceived  health  status  and  QOL  in  youth  with  CP  and  TDY,  while  controlling  for  baseline  activity 
performance  and  capacity,  age,  gender,  SES  and  current  day  outlook.  There  will  be  a  positive 
linear  relationship  by  activity  capacity  level  (GMFCS)  between  activity  performance  and  the 
health  status  physical  domain  (Child  Health  Questionnaire,  CHQ-P).  There  will  be  a  positive 
linear  relationship  by  activity  capacity  (GMFCS)  between  activity  performance  and  the  QOL 
relationship  domain  (Youth  Quality  of  Life,  YQOL-R).  The  relationship  of  activity  performance  to 
the  health  status  psychosocial  domain  (CHQ-PS)  and  the  QOL  self,  environment  and  general  QOL 
(YQOL-R:  S,  E  &  GQOL)  will  not  be  linear  by  activity  capacity  level. 

Aim  3.  Explore  a  model  specifying  the  influence  of  activity  capacity  and  activity  performance  on 
health  status  and  quality  of  life  controlling  for  baseline  activity  performance,  age,  gender,  SES, 
and  current  day  outlook. 

Technical  Approach:  This  is  a  multi-center  study  that  intends  to  study  the  health,  quality  of 
life,  and  activity  in  children  with  cerebral  palsy.  Children  with  the  diagnosis  of  cerebral  palsy, 
Gross  Motor  Function  Classification  System  (GMFCS)  levels  I-III  and  typically  developing  youth, 
ages  10  to  <  14  years,  with  the  ability  to  read  and  understand  at  the  10  year  age  level  will  be 
studied.  30  children  with  cerebral  palsy  and  10  children  that  are  typically  developing  that  meet 
inclusion  criteria  through  the  MAMC  study  site  will  be  enrolled,  as  well  as  one  parent/guardian  of 
each  child  enrolled  (40  parents).  Potential  study  participants  will  be  recruited  through  a  focused 
direct  mailing  of  an  approach  letter  introducing  the  project  to  the  guardians  of  children  with  CP 
and  typically  developing  youth  that  have  had  medical  care  at  the  MAMC  Developmental 
Pediatrics,  General  Pediatrics,  and  Family  Practice  clinics.  An  informational  letter  will  be  sent  to 
school  based  nurses,  physical  and  occupational  therapists,  or  other  health  care  providers  at 
military  facilities  in  Western  Washington.  The  letter  will  introduce  the  project,  state  that 
ambulatory  children  with  CP  and  TDY  are  being  sought  for  participation  in  the  study,  the 
inclusion  criteria  and  brief  description  of  the  project.  Local  health  care  providers  can  then 
approach  their  patients  about  interest  in  the  study  and  give  them  the  contact  information  of  the  PI 
and/or  contact  the  PI  for  further  information  about  the  project. 


287 


Once  consent  and  assent  have  been  attained,  there  will  be  two  research  visits  seven  days  apart  in 
the  participants'  home  at  their  convenience.  At  the  first  visit,  the  youth  will  be  asked  to  complete 
the  questionnaires  and  have  the  Step  Watch  calibrated  to  their  walking  pattern.  They  will  be 
asked  to  wear  the  Step  Watch  for  seven  days.  On  day  seven,  researchers  will  return  to  their  home 
to  download  the  information  from  the  Step  Watch  and  complete  appropriate  questionnaires. 
Parents/  guardians  will  be  asked  to  complete  the  appropriate  questionnaires  on  visit  day  one  and 
visit  day  seven.  For  specific  primary  and  secondary  outcomes,  design  and  procedures,  data 
preparation,  and  analysis,  see  sections  9.3  through  9.6  in  the  Master  Protocol. 

Progress:  Data  collection  was  completed  for  twenty  MAMC  subjects,  sixteen  during  FY06.  Data 
collection  continued  for  subjects  in  specific  categories  of  impairment  related  to  their  CP  from  the 
CHRMC  research  office,  for  a  total  of  over  100  patients  with  cerebral  palsy.  This  was  completed  in 
December  2005.  Data  analysis  began  and  Principal  PI  at  CHRMC  (K.  Bjornson)  defended  PhD 
dissertation  with  results.  The  protocol  remains  ongoing  at  MAMC.  Initial  manuscript  preparation 
underway  regarding  the  scope  of  activity  recorded  for  varying  degrees  of  physical  impairment  in 
children  with  cerebral  palsy. 


288 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204074 

Status:  Ongoing 

Title:  Survey  of  Chronic  Pain  and  Its  Effects  on  Youth  With  Disabilities 

Principal  Investigator:  COL  Beth  E.  Davis,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  Joyce  M.  Engel,  PhD,  OTR/L;  Kenneth  M.  Jaffe,  M.D.;  John  F. 
McLaughlin;  Mark  P.  Jensen,  PhD;  Dawn  Ehde,  PhD 

Start  -  Completion:  Funding: 

Periodic  Review: 

6/16/2004  -  May  2007  DCI 

8/10/2006 

Study  Objective:  This  study  has  two  specific  aims:  (1)  to  increase  our  understanding  of  the 
frequency  and  severity  of  pain  problems  in  youth  with  spina  bifida  (SB),  muscular  dystrophy  (MD), 
cerebral  palsy  (CP),  limb  deficiency  (LD),  and  spinal  cord  injury  (SCI);  and  (2)  to  develop  a 
biopsychosocial  model  for  the  study  of  chronic  pain  in  youth  with  disabilities. 

Technical  Approach:  This  study  uses  a  cross  sectional  design.  A  convenience  sample  of  100-150 
youths  will  be  interviewed  in-person  or  over  the  telephone  to  complete  a  standardized 
questionnaire  on  pain.  The  youths'  parent/guardian  will  also  be  invited  to  complete  a 
questionnaire  (assistance  will  be  provided  as  needed).  Subject  inclusion  criteria  include:  a  primary 
diagnosis  of  CP,  LD,  SCI,  SB,  or  MD,  a  chronological  age  range  of  8-to-20  years,  capacity  for 
expressive  communication  which  may  include  the  use  of  augmentative  communication  devices, 
English  as  the  primary  language,  and  no  more  than  mild  cognitive  impairment.  Subjects  will  be 
paid  $40.00  ($25.00  for  youth  and  $15.00  for  parent/guardian)  for  the  completion  of 
interview/questionnaire.  Potential  subjects  will  first  be  contacted  directly  by  Dr.  Beth  Ellen  Davis 
or  medical  personnel  involved  in  the  care  of  the  youths,  via  an  approach  letter  mailed  by  Dr.  Davis, 
or  posting  of  a  recruitment  flyer  .  Parents/guardians  and  young  adults  who  are  interested  in  the 
study  will  be  asked  to  return  an  interest/information  form  in  the  provided  postage-paid  envelope  to 
Dr.  Davis  at  the  Developmental  Pediatrics  Clinic  at  Madigan  Army  Medical  Center.  Dr.  Davis  will 
then  inform  UW  investigators  via  confidential  e-mail,  a  letter  sent  through  the  mail  or  telephone 
calls  of  those  families  interested  in  participating.  UW  research  personnel  will  then  contact  these 
potential  subjects.  Interested  parents/guardians  or  youth  may  also  contact  the  principal 
investigator  or  study  project  director  via  e-mail  or  telephone.  At  the  time  of  the  contact,  the 
purpose  and  procedures  of  the  study  will  be  explained  and  the  parent/guardian  will  have  the 
opportunity  to  ask  questions.  If  the  parent/guardian  and  youth  express  interest  in  the 
participating  in  the  study,  the  investigator  will  screen  to  insure  that  all  inclusion  criteria  have 
been  met  including  a  brief  cognitive  screening.  If  the  inclusion  criteria  are  met,  an  interview  will 
be  scheduled  at  a  time  and  place  (University  of  Washington  Medical  Center,  the  subject's  home,  or 
over  the  telephone  for  youths  without  speech  difficulties)  that  is  most  convenient  for  the  subjects. 
Assent  and  consent  forms  will  be  completed  by  the  youth  and  parent/guardian  prior  to  the 
initiation  of  the  interview/questionnaire.  A  brief,  standardized  cognitive  screening  will  also  be 
completed  prior  to  initiation  of  the  interview  (youth  subject  must  score  a  minimum  of  17/25  on  the 
modified  Mini  Mental  Status  Examination  to  be  eligible  for  participation.  A  subject  descriptive 
information  sheet  will  be  completed.  The  youth  will  then  be  interviewed  in-person  or  over  the 
telephone  by  a  study  investigator  or  trained  research  assistant  while  the  parent/guardian 
completes  a  disability  specific  form  and  a  written  questionnaire.  The  youth's  interview  and 
parent/guardian  questionnaire  each  will  take  approximately  10  to  50  minutes  to  complete 
depending  on  whether  or  not  the  youth  reports  recurrent,  bothersome  pain.  Response  keys  are 
used  throughout  the  interviews  to  facilitate  answering  questions.  All  data  will  be  entered  into  MS 
ACCESS.  After  all  data  have  been  entered,  variables  will  be  inspected  for  outliers  and  skewness 
and  adjusted  using  appropriate  transformations.  Descriptive  analysis  will  then  be  performed. 


289 


Progress:  In  the  last  year,  36  dyads  (parent  and  youth  with  spina  bifida)  have  completed  various 
(11)  comprehensive  surveys  regarding  pain  and  its  effects  on  daily  living.  An  abstract  describing 
the  early  results  of  the  nature  and  scope  of  pain  in  youth  with  spina  bifida  was  accepted  for 
presentation  at  two  national  meetings:  Poster  presentation  at  AACPDM,  Orlando  Fla.  15  Sep 
2005;  research  competition  at  the  AAP  Uniformed  Services  Pediatric  Seminar,  Portsmouth  VA, 
March  13,  2006  where  it  came  in  Second  Place  in  the  military  peer  reviewed  Margilith  Research 
Award.  Overall,  descriptive  information  revealed  that  recurrent  bothersome  pain  is  common  in 
youths  with  SB.  Despite  effectiveness  of  non-medical  interventions,  most  participants  reported  use 
of  opiates/narcotics  as  most  helpful  for  their  chronic  pain  symptoms.  Manuscript  preparation  is 
underway.  The  protocol  remains  ongoing;  the  next  step  is  to  analyze  the  Quality  of  Life  data  with 
the  reported  pain  frequency,  intensity  and  locations. 


290 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206049  Status:  Ongoing 

Title:  An  Observational  Study  to  Determine  the  Factors  Influencing  Bone  Mineral  Density  in 

Post-Menarchal  Adolescents  with  Neuromuscular  Disabilities 

Principal  Investigator:  MAJ  Michelle  K.  Ervin,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Beth  E.  Davis,  MC;  LTC  Stephen  M.  Yoest,  MC;  COL  (Ret) 

Patrick  C.  Kelly,  D.O.;  LTC  Antonio  G.  Balingit,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

3/7/2006  -  Jun  2007  DCI  N/A 

Study  Objective:  To  determine  bone  mineral  density  measurements  by  use  of  DEXA  technique  at 
the  distal  femur,  in  a  heterogeneous  group  of  post-menarchal  females  with  neuromuscular 
disabilities  and  compare  to  previously  published  reference  data  of  age-matched  normal  controls.  To 
describe  the  associations  between  bone  mineral  density  measurement  and  multivariate  factors 
such  as:  1)  anti- epileptic  medication  use,  (2)  mobility  status  as  defined  by  the  Gross  Motor 
Function  Classification  System  (GMFCS;  see  appendix  for  description  of  this  scale),  (3)  Body  mass 
index  (BMI),  (4)  Tanner  staging,  and  (5)  hormonal  contraceptive  use  while  controlling  for 
nutritional  intake,  specifically  calcium  and  vitamin  D. 

Technical  Approach:  This  observational  pilot  study  will  evaluate  the  bone  mineral  density  in  a 
heterogeneous  group  of  45  post-menarchal  females  ages  11  through  24  with  neuromuscular 
disabilities  that  meet  the  inclusion  criteria.  The  change  in  bone  mineral  density  will  be 
descriptively  compared.  Potential  subjects  will  be  recruited  through  a  focused  direct  mailing  of  an 
approach  letter  introducing  the  project  to  the  subject  and/or  guardians  of  eligible  adolescent 
females  receiving  care  at  the  Madigan  Army  Medical  Center  Pediatric  Clinic,  Adolescent  Clinic, 
and  Developmental-Behavioral  Clinic.  The  letter  will  introduce  the  project,  and  state  that  post- 
menarchal  females  with  neuromuscular  disabilities  are  being  sought  for  participation  in  the  study, 
the  inclusion  criteria  and  a  brief  description  of  the  project.  Once  consent,  assent  or  surrogate 
consent  has  been  obtained,  a  clinic  appointment  will  be  scheduled  with  a  member  of  the 
investigative  team  to  conduct  an  intake  history  and  physical  exam,  and  initiate  dietary 
assessment  through  the  use  of  a  three  day  diet  diary.  Those  participants  identified  as  having 
insufficient  calcium  and/or  vitamin  D  intake  will  be  provided  with  supplemental  therapy.  Subjects 
will  have  distal  femur  bone  mineral  density  measured  at  baseline,  6  months  and  12  months.  No 
current  reference  normative  data  exists  for  this  population.  Once  all  of  the  data  is  collected  BMD 
measurements  will  be  descriptively  compared  using  multivariate  logistical  regression  to  determine 
significance  of  osteopenia  risk  factors  identified  for  each  subject. 

Progress:  This  protocol  remains  open  to  enrollment,  with  18  subjects  enrolled  during  FY06.  All  18 
subjects  completed  the  initial  baseline  bone  mineral  density  scan,  and  one  patient  has  returned  for 
the  six- month  interval  scan.  The  study  staff  is  currently  in  the  process  of  scheduling  six- month 
interval  scans  for  the  remaining  17  subjects.  The  IRB  recently  approved  an  amendment  to  include 
a  lumbar  spine  DEXA,  along  with  the  already  approved  distal  femur  DEXA  when  subjects  return 
for  their  six- month  and  twelve-month  follow  up  visits.  One  study  patient  died;  however,  this  death 
was  considered  unrelated  to  study  participation.  Patient  follow-up  visits  and  study  recruitment 
will  continue  during  FY07. 


291 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205138 

Status:  Ongoing 

Title:  Evaluation  of  Serologic  Responses  to  Fluzone®  in  Infants  >  6  Months  of  Age  Who  Did  or 

Did  Not  Receive  Fluzone  Vaccine  at  2  Months  of  Age 

Principal  Investigator:  COL  Mary  P.  Fairchok,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  Sue  E.  Chambers,  RN 

Start  -  Completion:  Funding: 

11/17/2005  -  Sep  2006  Sanofi  Pasteur  via  The  Geneva  Foundation 

Periodic  Review: 

9/26/2006 

Study  Objective:  To  demonstrate  the  safety  and  immunogenicity  of  Fluzone  vaccine 
administered  in  6  month  olds  who  have  previously  received  this  immunization  compared  to  6 
month  olds  who  have  not  received  this  vaccine  previously. 


Technical  Approach:  This  is  an  observational  and  descriptive  study  that  will  provide 
preliminary  comparative  information  about  the  safety  and  immunogenicity  of  Fluzone  vaccine 
among  children  who  were  given  Fluzone  vaccine  at  2  months  of  age  as  part  of  MAMC  protocol 
205034  (Group  1)  versus  children  who  have  never  received  influenza  vaccine  (Group  2).  All 
participants  will  be  enrolled  after  obtaining  informed  consent  from  their  parent  or  guardian. 

At  study  visit  1,  all  participants  will  undergo  informed  consent,  and  a  medical  history  and  directed 
physical  exam  will  be  conducted.  All  participants  will  then  receive  one  0.25  mL  intramuscular 
injection  of  Fluzone®.  Both  groups  will  be  provided  with  a  diary  card  to  take  home  at  this  visit, 
recording  solicirted  and  unsolicited  local  and  systemic  adverse  effects  of  the  vaccines  as  well  as 
daily  temperatures  for  the  7  days  after  the  visit. 

At  study  visit  2,  a  blood  sample  will  be  collected  from  all  subjects,  and  both  groups  will  receive  a 
second  0.25ml  intramuscular  injection  of  Fluzone®.  Interim  histories  and  diary  cards  will  be 
collected  and  a  second  diary  card  will  be  provided. 

At  study  visit  3,  a  blood  sample  will  be  collected  from  all  subjects.  Diary  cards  and  interim  history 
will  be  obtained.  There  will  be  a  follow  up  contact  by  phone  of  all  study  participants  at  6  months 
after  visit  the  last  dose  of  Fluzone®  to  solicit  adverse  events. 

Other,  non- study,  vaccinations  may  be  given  at  any  study  visit  or  at  any  time  beginning  15  days 
following  Visit  2.  No  vaccinations  may  be  given  between  Visit  1  and  Visit  2,  nor  in  the  14  days 
preceding  Visit  1  or  following  Visit  2. 

Outcome  variables  for  safety  include  1.  Frequency  and  percentage  of  subjects  who  had  solicited 
injection  site  and  systemic  reactions  2.  Frequency  of  subjects  reporting  medically  attended 
unsolicited  adverse  events  and  serious  adverse  events  and  the  frequencies  of  these  events 

Outcome  variables  for  immunogenicity  include  1.  Post-vaccination  seroprotection  rates:  the 
proportion  of  subjects  with  HAI  titers  (?  1:40)  for  influenza  strains  following  each  vaccination. 

2. Post-vaccination  geometric  mean  of  anti-HAI  titers  for  influenza  strains  following  each 
vaccination.  3.Post-vaccination  GMTs  of  anti-pertussis  (PT,  FHA,  PRN,  and  FIM),  tetanus, 
diphtheria,  and  pneumococcal  antigens.. 

Data  analysis  plan:  The  number  of  subjects  enrolled  and  their  age  at  enrollment  (mean,  median, 
and  minimum  and  maximum),  sex,  and  ethnic  origin  will  be  summarized  for  each  group,  as  well  as 
the  number  and  description  of  protocol  violations. 


292 


Continuous  variables  will  be  presented  by  summary  statistics  (eg,  mean  and  standard  deviation 
for  the  non-immunogenicity  endpoints,  and  geometric  means  and  their  confidence  intervals  for  the 
immunogenicity  endpoints),  and  categorical  variables  will  be  presented  by  frequency  distributions 
(frequency  counts,  percentages,  and  their  confidence  intervals). 

Progress:  This  protocol  closed  to  enrollment  with  fifteen  subjects  enrolled  during  FY06;  two 
subjects  in  Group  1,  and  thirteen  subjects  in  Group  2.  Twelve  subjects  completed  all  study 
interventions.  Three  were  withdrawn  prior  to  study  completion;  one  left  the  MAMC  area,  one 
parent  requested  to  withdraw  and  one  for  non-compliance  with  study  requirements.  Six  month 
follow-up  visits  were  completed  on  eleven  subjects;  four  subjects  were  considered  lost  to  follow-up 
after  phone  contact  was  unsuccessful  and  certified  letters  sent.  Data  analysis  is  in  progress. 


293 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203052  Status:  Completed 

Title:  Improving  the  Delivery  of  Influenza  Vaccine  to  Young  Children:  A  Comparison  of  Two 

Influenza  Vaccine  Regimens 

Principal  Investigator:  COL  Mary  P.  Fairchok,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  Janet  A.  Englund,  M.D.;  Kathleen  M.  Neuzil,  M.D.,  M.P.H. 

Start  -  Completion:  Funding:  Periodic  Review: 

4/21/2003  -  Mar  2004  Dr.  Englund  (UW)  via  Proffer  3/22/2005 

Study  Objective:  To  compare  reactogenicity  and  immunogenicity  of  two  different  dosing 
regimens  of  standard  licensed  trivalent  inactivated  influenza  virus  vaccines  (TIV)  in  healthy 
young  children  ages  6-23  months. 

Technical  Approach:  This  is  a  prospective,  randomized,  open-label  clinical  trial  comparing 
reactogenicity  and  Immunogenicity  of  two  different  dosing  regimens  of  standard  licensed  trivalent 
inactivated  influenza  (TIV)  vaccines  in  healthy  young  children  ages  6-23  months.  Approximately 
150  patients  will  be  enrolled  her  at  MAMC.  Patients  will  be  randomized  to  either  the  "standard"  or 
the  "early"  dosing  schedules.  Both  groups  will  receive  two  doses  of  licensed  influenza  vaccine  (TIV) 
in  the  fall.  However  the  "early"  group  will  receive  an  additional  dose  of  the  licensed  TIV  at  the 
time  of  enrollment.  Antibody  responses  following  the  two  doses  of  the  vaccine  in  the  fall  (standard 
group)  will  be  compared  with  antibody  responses  following  one  dose  of  vaccine  in  the  spring  and  a 
second  dose  in  the  fall  (early  group).  A  diary  of  the  injection  site  and  systemic  symptoms  and  signs 
for  5  days  following  the  inoculation  will  be  maintained  by  the  parents.  A  phone  call  will  be  made  to 
the  parent  beginning  three  days  after  the  immunization  to  verify  reactions  and  solicit  adverse 
experiences.  Blood  samples  will  be  collected  at  two  time  points. 

Progress:  This  protocol  is  closed  to  enrollment,  with  126  subjects  consented;  117  received  at  least 
one  Fluzone  vaccine  as  part  of  the  study  procedures.  Out  of  117  subjects,  84  were  contacted  and  six 
month  follow-up  information  was  obtained  with  no  adverse  events  reported.  Following  failed  phone 
contact  attempts  and  return/nonresponse  to  certified  letters,  33  subjects  were  lost  to  follow-up  for 
the  scheduled  six  month  follow-up.  The  six  month  follow-up  data  was  submitted  for  analysis.  Final 
results  are  pending. 


294 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205137 

Status:  Terminated 

Title:  Safety  and  Immunogenicity  of  Fluzone®  Influenza  Virus  Vaccine  (2005-2006  Formulation) 
Among  Healthy  Children  6  to  12  Weeks  of  Age 

Principal  Investigator:  COL  Mary  P.  Fairchok,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  Sue  E.  Chambers,  RN 

Start  -  Completion:  Funding: 

1/24/2006  -  Sep  2006  Sanofi  Aventis  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  To  demonstrate  the  safety  of  Fluzone  vaccine  administered  to  2-month-old 
children 


Technical  Approach:  This  is  a  multicenter,  double-blinded  placebo  controlled  trial  to  compare 
the  safety  and  immunogenicity  of  Fluzone®  vaccine  among  healthy  children  aged  6  to  12  weeks  of 
age  at  enrollment  who  are  given  Fluzone  vaccine  plus  concomitant  vaccines  versus  control  children 
given  placebo  plus  concomitant  vaccines.  The  investigational  group  (Group  1)  will  consist  of  up  to 
60  subjects  enrolled  at  MAMC.  The  control  group  (Group  2)  will  consist  of  up  to  30  children 
enrolled  at  MAMC.  Subjects  will  be  randomized  to  the  investigational  or  control  group  at  a  ratio  of 
2:1.  All  participants  will  be  enrolled  after  obtaining  informed  consent  from  their  parent  or 
guardian. 

At  study  visit  1,  Group  1  participants  will  receive  one  0.25  mL  intramuscular  injection  of  Fluzone® 
in  addition  to  the  routinely  recommended  concomitant  vaccines  of  DAPTACEL,  ActHIB  and 
Prevnar.  Group  1  participants  will  also  receive  the  routinely  recommended  Hepatitis  B  vaccine 
and  Inactivated  polio  vaccine  at  either  the  first  study  visit,  the  second  study  visit,  or  any  time 
between  the  2  study  visits  that  is  at  least  7  days  apart  from  a  study  visit.  At  study  visit  1,  Group  2 
participants  will  receive  one  .25ml  intramuscular  injection  of  saline  placebo  in  addition  to  the 
routinely  recommended  concomitant  vaccines  of  DAPTACEL,  ActHIB  and  Prevnar.  Group  2 
participants  will  also  receive  the  routinely  recommended  Hepatitis  B  vaccine  and  Inactivated  polio 
vaccine  at  either  the  first  study  visit,  the  second  study  visit,  or  any  time  between  the  2  study  visits 
that  is  at  least  7  days  apart  from  a  study  visit.  Both  groups  will  be  provided  with  a  diary  card  to 
take  home  at  this  visit,  recording  solicirted  and  unsolicited  local  and  systemic  adverse  effects  of 
the  vaccines  as  well  as  daily  temperatures  for  the  7  days  after  the  visit. 

At  study  visit  2,  Group  1  will  receive  a  second  0.25ml  intramuscular  injection  of  Fluzone®  in 
addition  to  Inactivated  polio  vaccine  and/or  Hepatitis  B  vaccine  in  the  opposite  thigh  if  not 
previously  given.  Group  2  will  receive  a  second  0.25  ml  intramuscular  injection  of  saline  placebo  in 
addition  to  Inactivated  polio  vaccine  and/or  Hepatitis  B  vaccine  in  the  opposite  thigh  if  not 
previously  given.  Interim  histories  and  diary  cards  will  be  collected  and  a  second  diary  card  will 
be  provided. 

At  study  visit  3,  a  blood  sample  will  be  collected  from  all  subjects.  Diary  cards  and  interim  history 
will  be  obtained.  All  subjects  will  then  receive  the  routinely  recommended  childhood  vaccines  of 
DAPTACEL,  ActHIB,  Prevnar  and  Inactivated  polio  vaccine. 

At  study  visit  4,  a  blood  specimen  will  be  collected  from  all  subjects. 

There  will  be  a  follow  up  contact  by  phone  of  all  study  participants  at  6  months  after  visit  2  to 
solicit  adverse  events. 

Outcome  variables  for  safety  include  1. frequency  and  percentage  of  subjects  who  had  solicited 


295 


injection  site  and  systemic  reactions.  2.  Frequency  of  subjects  reporting  any  unsolicited  adverse 
events  and  serious  adverse  events  and  the  frequencies  of  these  events.  3.  Immediate  reactions, 
serious  adverse  events  and  adverse  events  in  participants  who  withdraw  due  to  an  adverse  event. 

Outcome  variables  for  immunogenicity  include  1.  Geometric  mean  of  anti-HI  titers  (GMT) 
following  the  second  of  two  Fluzone  vaccinations  given  approximately  one  month  apart 
2.  Seroprotection  rate:  The  proportion  of  subjects  with  seroprotective  titer  to  influenza 
or  concomitant  vaccines. 

Data  analysis  plan:  Descriptions  of  the  populations  will  be  presented.  The  number  of  subjects 
enrolled  and  their  age  at  enrollment  (mean,  median,  and  minimum  and  maximum),  sex,  and 
ethnic  origin  will  be  summarized  for  each  group,  as  well  as  the  number  and  description  of  protocol 
violations.  Continuous  variables  will  be  presented  by  summary  statistics  (eg,  mean  and  standard 
deviation  for  the  non-immunogenicity  endpoints,  and  geometric  means  and  their  confidence 
intervals  for  the  immunogenicity  endpoints),  and  categorical  variables  will  be  presented  by 
frequency  distributions  (frequency  counts,  percentages,  and  their  confidence  intervals). 

Progress:  The  PI  reported  the  protocol  terminated  at  MAMC  1  February  2006,  due  to  the  sponsor 
meeting  enrollment.  CRADA/SOW  approval  was  received  25  January  2006,  which  was  not  in  time 
to  initiate  enrollment  of  MAMC  subjects. 


296 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205034 

Status:  Completed 

Title:  Safety  and  Immunogenicity  of  Influenza  Virus  Vaccine  Fluzone®  2004-2005  Among 

Healthy  Children  2  Months  vs  6  Months  of  Age 

Principal  Investigator:  COL  Mary  P.  Fairchok,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  Janet  A.  Englund,  M.D.;  Sue  E.  Chambers,  RN 

Start  -  Completion:  Funding: 

4/18/2005  -  Jan  2006  Aventis  Pasteur  via  University  of  Washington 

Periodic  Review: 

1/24/2006 

Study  Objective:  To  determine  the  safety  and  immunogenecity  of  the  inactivated  influenza 
vaccine  (Fluzone)  in  healthy  children  2  months  of  age  compared  to  a  control  group  of  6  month  olds 


Technical  Approach:  This  is  a  multicenter,  open  label,  double-arm.  observational  and 
descriptive  study  that  will  provide  preliminary  comparative  information  about  the  safety  and 
immunogenicity  of  Fluzone®  vaccine  among  children  aged  6  to  12  weeks  (the  investigational 
group)  versus  children  aged  24  to  36  weeks  (the  control  group).  The  study  is  not  designed  to 
achieve  any  preset  statistical  power,  and  no  hypotheses  will  be  tested.  At  MAMC,  we  anticipate 
enrolling  a  total  of  100  patients  with  50  infants  enrolled  in  the  investigational  group  and  50 
enrolled  in  the  control  group.  Study  participants  will  receive  one  0.25  mL  intramuscular  injection 
of  Fluzone®  at  the  time  of  enrollment.  A  blood  specimen  will  be  collected  at  that  visit,  and  a  7  day 
diary  card  will  be  provided  to  record  any  adverse  events  as  well  as  daily  temperatures  for  the  7 
days  following  the  immnization.  At  visit  2,  21-35  days  following  enrollment,  a  second 
intramuscular  injection  of  0.25  mL  of  Fluzone®  will  be  given,  interim  history  and  the  first  diary 
will  be  collected  and  another  diary  card  provided.  At  Visit  3,  21-35  days  after  Visit  2,  a  second 
blood  specimen  will  be  collected,  interim  history  and  the  second  diary  card  will  also  be  collected.  A 
6  month  followup  visit  will  be  conducted  on  day  210-240  following  enrollment  at  which  time  an 
interim  history  will  be  obtained.  Outcome  variables  include  a  comparison  of  mean  geometric  titers 
in  each  study  group  against  the  three  components  of  the  influenza  vaccine  pre  and  post 
vaccination,  a  comparison  of  the  seroprotection  and  seroconversion  rates  in  each  group  against 
each  of  the  3  components  of  the  vaccine,  and  record  of  adverse  events  after  each  vaccine. 

Data  analysis:  The  number  of  subjects  enrolled  and  their  age  at  enrollment  (mean,  median,  and 
minimum  and  maximum),  sex,  and  ethnic  origin  will  be  summarized  for  each  group,  as 
well  as  the  number  and  description  of  protocol  violations.  Continuous  variables  will  be  presented 
by  summary  statistics  (eg,  mean  and  standard  deviation  for  the  non-immunogenicity  endpoints, 
and  geometric  means  and  their  confidence  intervals  for  the  immunogenicity  endpoints),  and 
categorical  variables  will  be  presented  by  frequency  distributions  (frequency  counts,  percentages, 
and  their  confidence  intervals.  Additionally,  the  frequency  and  percentage  of  subjects  who  had 
solicited  local  and  systemic  reactions  and  their  95%  two-sided  exact  confidence  intervals  will  be 
calculated.  Also,  the  frequency  of  subjects  reporting  medically  attended  unsolicited  adverse  events 
and  serious  adverse  events  and  the  frequencies  of  these  events  will  be  calculated. 

Progress:  This  protocol  was  reported  completed  in  July  2006;  final  site  visit  has  been  conducted 
by  the  study  sponsor.  A  total  of  40  patients  enrolled  at  MAMC  in  FY  2005  (May-Jul);  38  received 
all  study  treatment/procedures,  two  patients  withdrew  after  Visit  1:  both  received  1  dose  of 
Fluzone  and  blood  draw.  Reason  for  withdraw:  one  patient:  moved  from  state  related  to  parent 
deployment  and  one  patient  self  withdrew  after  serious  adverse  event  (fever  presented  at  ER  and 
hospitalized  for  R/O  sepsis).  This  adverse  event  was  reported  to  the  IRB  and  resulted  in  a  revision 
of  the  informed  consent  document. 


297 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205139  Status:  Ongoing 

Title:  The  Impact  of  Human  Metapneumovirus  Versus  other  Common  Respiratory  Viruses  in 

Infants  in  Fulltime  Daycare 

Principal  Investigator:  COL  Mary  P.  Fairchok,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  Sue  E.  Chambers,  RN;  Melinda  L.  Behrens,  MD;  MAJ  Loranee  E. 

Braun,  MC;  Janet  Englund,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

1/25/2006  -  Oct  2006  UW  via  The  Geneva  Foundation  9/26/2006 

Study  Objective:  To  determine  the  impact  of  common  respiratory  viruses  on  infants  attending 
fulltime  daycare.  Specific  objectives  include  the  comparison  of  duration,  lost  days  from  daycare, 
complications  and  incidence  of  the  viruses  studied  in  this  population. 

Technical  Approach:  We  will  be  performing  a  prospective  descriptive  study  on  the  duration, 
clinical  characteristics,  lost  days  from  daycare,  complications  and  incidence  of  the  viruses  studied, 
with  particular  attention  to  the  comparison  of  these  characteristics  of  HMPV  infection  relative  to 
the  other  viruses  studied.  We  will  conduct  rolling  enrollment  up  to  125  subjects/month  attending 
at  least  20  hours  of  daycare  per  week  at  one  of  the  Fort  Lewis  Daycare  Centers.  Subjects  enrolled 
will  be  6  weeks-24  months  on  enrollment.  We  will  obtain  baseline  enrollment  clinical  and 
demographic  data  and  we  will  then  follow-up  with  all  subjects  via  mailers  or  telephone  calls  on  a 
monthly  basis,  as  well  as  with  notices  posted  at  the  daycare,  to  determine  presence  of  development 
of  acute  upper  respiratory  tract  infections.  If  any  2  out  of  our  5  defined  symptoms  for  respiratory 
tract  infection  should  develop,  subjects  will  be  given  a  study  visit.  At  that  visit,  a  standardized 
health  questionnaire  will  be  completed,  and  a  nasal  swab  for  reverse  transcriptase  per  for 
Respiratory  Syncytial  Virus,  Human  Metapneumovirus,  Parainfluenza  1,2,3  and  4,  rhinovirus, 
coronavirus,  influenza  A  and  B  viruses,  and  adenovirus  will  be  obtained.  A  separate  clinical  visit 
with  a  health  care  provider  will  be  provided  if  additional  assessment  and  intervention  is 
necessary.  Any  positive  pers  would  then  undergo  quantitative  assay.  Parents  will  be  provided  with 
a  diary  to  complete  and  mail  back  recording  symptoms  and  duration  of  the  illness  as  well  as 
impact  on  work  and  daycare.  Parents  will  be  called  for  any  positive  per  results  and  given  further 
information  about  the  virus  identified.  All  subjects  will  be  followed  from  the  time  of  enrollment 
until  31  October  2006  unless  disenrolled.  Outcome  variables  include  the  incidence  of  acute  upper 
respiratory  tract  infections  attributable  to  HPMV  versus  the  other  study  viruses  in  the  population, 
attack  rate  of  each  virus  in  the  daycare  per  month,  characteristics  of  the  viral  infections,  impact 
on  the  family  in  days  missed  from  work  or  daycare,  and  duration  of  infection.  Co-infection  with 
other  respiratory  pathogens  and  secondary  infections  will  also  be  recorded.  Method  of  analysis  of 
these  variables  will  be  conducted  using  descriptive  statistics 

Progress:  This  protocol  remains  open  to  enrollment,  with  54  subjects  enrolled  during  FY06.  Ten 
patients  have  been  withdrawn;  five  for  ineligibility  (removed  from  daycare)  and  five  moved  out  of 
the  Fort  Lewis  area.  The  remaining  44  subjects  are  receiving  ongoing  study  treatment  per 
protocol.  Presently  83  daycare  visits,  48  health  care  provider  visits,  and  131  swabs  have  been 
performed. 


298 


Detail  Summary  Sheet 

Date:  30  Sep  06 

Number:  206035 

Status:  Ongoing 

Title:  Military  Children  at  Risk  ■ 

■  Enhancing  Quality  of  Life  (mCARE)  Needs  Assessment 

Principal  Investigator:  Karen  L.  Fitzgerald,  RN,  PhD 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  Janice  L.  Hansen,  PhD;  Virgina  F.  Randall; 

Jason  P.  Cervenka 

Start  -  Completion: 

Funding: 

Periodic  Review: 

12/20/2005  -  Dec  2006 

TATRC  via  MIPR 

N/A 

Study  Objective:  To  delineate  the  needs  of  children  with  life-threatening  illnesses  and  their 
families  who  are  eligible  for  care  in  the  Military  Health  System  (MHS).  To  delineate  the 
educational  needs  of  pediatricians  (pediatric  residents,  general  pediatricians  and  pediatric  sub¬ 
specialists)  that  relate  to  providing  and  coordinating  care  for  children  with  life  threatening 
illnesses  and  their  families.  To  analyze  the  TRICARE  benefit  and  services  provided  by  the  MHS  in 
relation  to  the  needs  of  children  with  life  threatening  illnesses  and  their  families.  To  develop 
recommendations  for  a  program  to  provide  health  care  services  to  military  children  with  life 
threatening  illnesses  and  their  families. 

Technical  Approach:  This  is  Phase  II  of  a  needs  assessment  of  military  families  with  children 
with  life-threatening  illnesses,  using  a  case  study  methodology.  Phase  II  will  include  case  studies 
of  the  areas  surrounding  the  Madigan  AMC,  Naval  Medical  Center,  San  Diego  Munson  AHC  at  Ft. 
Leavenworth,  KS.  Altogether,  there  will  be  case  studies  of  the  National  Capitol  Area  (NCA),  areas 
surrounding  installations  with  major  medical  centers,  and  the  area  surrounding  a  small 
installation  with  limited  services  available  through  the  direct-care  MHS.  Data  collection  will 
include  interviews  and/or  focus  groups  with  parents,  interviews  and  focus  groups  with  health  care 
providers,  and  collection  of  TRICARE  data  regarding  case  management  and  utilization  of  care. 
Three  existing  surveys  (the  FACCT  End-of-Life  Survey,  Medical  Home  Assessment  Tools,  and  a 
survey  of  the  quality  of  life  of  caregivers  previously  developed  by  the  investigators  with  parent 
advisors)  will  provide  the  basis  for  interview  and  focus  group  questions.  Needs  identified  will  be 
compared  to  the  services  available  at  each  site  and  then  to  the  services  covered  by  the  TRICARE 
benefit.  In  collaboration  with  other  partners  in  the  mCARE  project,  needs  identified  by  parents  of 
children  with  life-threatening  illnesses  and  health  care  providers  who  provide  care  for  them  will  be 
compared  to  services  provided  by  the  MHS,  the  TRICARE  benefit,  and  community  resources.  The 
assessment  will  also  describe  access  and  barriers  to  access  for  services  from  these  three  sources. 
Subsequently,  the  mCARE  project  team  will  propose  a  model  of  care  for  military  children  and  their 
families  that  will  provide  a  coordinated,  comprehensive,  family-centered  approach  to  care  from  the 
time  of  diagnosis  of  a  life-threatening  illness  through  the  time  of  bereavement  of  families.  This 
proposal  also  adds  the  following  components  to  the  needs  assessment:  development  of  an  advisory 
group  of  parents  in  the  NCA,  a  collaboration  with  Family  Medicine,  adaptation  to  this  population 
of  a  previously-developed  measure  of  quality  of  life  of  caregivers,  technical  assistance  in  defining 
eligibility  criteria,  and  participation  in  evaluation  of  program  components  piloted  by  other  mCARE 
project  team  members  (respite  care  and/or  care  coordination). 

Progress:  During  2006,  data  was  gathered  from  MAMC,  San  Diego  Naval  Medical  Center, 
Wright-Patterson  Medical  Center,  and  within  the  NCA.  Overall  100  health  care  providers  and  93 
parents  enrolled;  of  these  participants,  28  health  care  providers  and  35  parents  were  from  MAMC. 
Analysis  of  parent  transcripts  from  the  NCA  has  yielded  a  preliminary  list  of  themes,  which  has 
begun  to  identify  the  needs  of  families  and  the  difficulties  they  face.  Analysis  of  health  care 
provider  transcripts  from  NCA  and  MAMC  has  yielded  a  separate  preliminary  list  of  themes, 
which  has  also  begun  to  identify  the  needs  of  health  care  providers  themselves  and  those  they 
recognize  facing  the  families  they  see. 


299 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205065  Status:  Ongoing 

Title:  Staphylococcus  Aureus  Intestinal  Colonization  Among  Healthy  Infants 
Principal  Investigator:  LTC  Dolores  M.  Gries,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  Curtis  J.  Donskey,  M.D.;  CPT  Tamatha  F.  Zemzars,  MC;  CPT  Katy 
J.  Gibson,  MC;  Meera  R.  Iyer,  M.D.;  MAJ  Steven  D.  Mahlen,  MS;  Mary  L.  Myers,  MT;  CPT  Elisa 
D.  O’Hern,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/19/2005  -  May  2006  DCI  4/25/2006 

Study  Objective:  (1)  To  perform  a  prospective  survey  to  examine  the  incidence  and  density  of  S. 
aureus  carriage  among  healthy  infants.  (2)  To  evaluate  whether  infants  with  increased  density  of 
S.  aureus  in  stool  have  increased  frequency  of  environmental  and  skin  contamination.  (3)  To 
examine  the  molecular  epidemiology  of  S.  aureus  isolates  among  healthy  infants  and  their 
mothers.  (4)  To  determine  the  potential  for  MRSA  and  other  nosocomial  pathogens  to  grow  in  stool 
of  healthy  infants.  (5)  To  determine  the  incidence  of  S.  aureus  infection  in  healthy  colonized 
infants  during  the  first  2  weeks  of  life. 

Technical  Approach:  A  12-month  prospective  study  will  be  conducted  in  the  MAMC  Newborn 
Unit  and  Well  Child  Clinic.  Cultures  of  anterior  nares,  skin,  discarded  stool,  and  environmental 
surfaces  in  the  room  of  infants  will  be  obtained.  Cultures  of  the  anterior  nares  of  the  mother  will 
be  obtained.  Samples  will  be  analyzed  for  the  presence  of  MSSA  or  MRSA.  Stool  samples  will  be 
evaluated  for  the  ability  of  MRSA  and  other  important  nosocomial  pathogens  to  grow  in  stool 
specimens.  Molecular  typing  using  pulsed-field  gel  electrophoresis  will  be  performed  at  the 
Cleveland  VA  Medical  Center  to  identify  the  potential  source  of  the  bacteria. 

Progress:  This  protocol  remains  open  to  enrollment  with  thirteen  patients  enrolled  at  MAMC. 

The  incidence  of  staph  colonization  thus  far  remains  at  approximately  15%.  No  MRSA  has  been 
found.  Enrollment  and  follow-up  remains  ongoing. 


300 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204097  Status:  Terminated 

Title:  Effect  of  Immunomodulatory  Diet  Upon  5-Fluorouracil  Induced  Oral  and  Intestinal 

Mucostitis  in  Golden  Syrian  Hamsters  (Mesocricetus  auratus) 

Principal  Investigator:  CPT  Wendy  T.  Harsha,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  CPT  Wayne  J.  Harsha,  MC;  CPT  Ellina  Kalandarova,  MC;  COL 

James  M.  Noel,  Jr.,  MC;  ETC  Robert  G.  Irwin,  MC;  CPT  Patrick  M.  McNutt,  MS;  CPT  Roy  F. 

Thomas,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

8/11/2004  -  Jul  2007  Society  of  Military  Otolaryngologists  Research  8/10/2005 

Grant  via  T.R.U.E 

Study  Objective:  Cancer  chemotherapy  often  causes  damage  to  the  lining  of  the  mouth  and  gut, 
known  as  mucositis.  When  mucositis  occurs  in  the  mouth  and  throat,  the  patients  suffer  from 
painful  ulcerations  that  limit  their  ability  to  talk  and  eat.  Additionally,  mucositis  in  the  gut 
predisposes  patients  to  secondary  problems  such  as  infections,  nausea,  vomiting  and  malnutrition. 
A  number  of  growth  factors  and  cytokines  (signaling  molecules  of  the  body)  have  been  implicated 
in  intestinal  and  oral  regeneration  in  various  animal  models  involving  mucositis.  These  factors 
include  glutamine,  transforming  growth  factors  alpha  and  beta,  insulin-like  growth  factor,  and 
other  cytokines.  It  is  possible  to  reproduce  intestinal  and  oral  mucositis  in  laboratory  animals 
with  systemic  injections  of  5-Fluorouracil  (5-FU). 

Technical  Approach:  The  aim  is  to  address  the  5-FU  induced  damage  to  the  oral  and 
gastrointestinal  tract  of  hamsters.  The  hamsters  will  be  fed  either  a  standard  diet  or  a  polymeric 
formula  containing  glutamine,  transforming  growth  beta  (TGF-Beta)  and  short  chain  fatty  acids 
(SCFAs).  Objective  and  semi-objective  measurements  of  oral  ulceration  will  be  evaluated  daily 
and,  after  sacrifice,  both  the  oral  and  gastointestinal  mucosa  will  be  evaluated  by  an  objective 
pathologist  who  is  unaware  of  the  groups  from  which  the  samples  came.  In  addition,  during  the 
study  we  will  measure  nutrition  parameters  to  include  daily  weights,  albumin  levels  and 
bicarbonate  levels. 

Progress:  We  completed  both  the  pilot  portion  of  the  protocol  and  the  first  phase  of  study 
hamsters.  We  made  some  changes  to  the  protocol  based  on  results  seen  in  the  pilot  study  then 
proceeded  with  the  first  phase  of  study  hamsters.  In  the  42  study  hamsters,  the  preliminary 
statistics  show  that  the  study  hamsters  showed  improved  weight  and  food  intake  versus  the 
control  animals.  The  GI  data  is  still  in  the  process  of  being  analyzed,  and  the  BrDU  data  is  still 
waiting  to  be  run.  The  cheek  pouch  data  has  shown  a  trend  toward  improvement  in  the  study 
animals. 


301 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206021  Status:  Ongoing 

Title:  EKG  Screening  in  ROTC  Cadets;  Is  It  Useful? 

Principal  Investigator:  CPT  Erik  R.  Johnson,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  CPT  Mark  J.  Devenport,  MC;  LTC  Robert  A.  Puntel,  MC;  LTC 
Telita  Crosland,  MC;  MAJ  Victoria  W.  Cartwright,  MC;  MAJ  John  A.  Edwards,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

11/30/2005  -  Jul  2006  DCI  N/A 

Study  Objective:  (1)  To  determine  how  often  screening  electrocardiograms  (EKG's)  in  ROTC 
cadets  disclose  abnormal  EKG  findings,  (2)  which  specific  cardiac  abnormalities  are  discovered,  (3) 
what  percentage  of  abnormal  screening  EKG's  disclosed  life-threatening  or  serious  cardiac  illness 
that  require  further  consultation  and  (4)  what  percentage  of  cadets  are  disqualified  from  entering 
flight  school  due  to  EKG  findings  and/or  further  evaluation. 

Technical  Approach:  This  is  a  retrospective  study  designed  to  have  no  impact  whatsoever  on  the 
routine  care  of  the  ROTC  candidates  seen  at  Ft.  Lewis,  Washington  during  the  Summer  of  2005  as 
part  of  Warrior  Forge.  Each  year,  approximately  500-700  cadets  undergo  evaluation  for  flight 
status  as  an  additional  part  of  their  ROTC  experience  (current  year's  estimate  is  around  600)  and 
receive  screening  EKGs  in  addition  to  other  routine  medical  evaluations.  Data  [age,  sex,  height, 
weight,  abnormalities  listed  on  EKG,  any  consultations  or  further  evaluations  made,  specifically 
cardiology  referral  (yes/no  and  descriptive  clinical  findings  of  referral)]  will  be  obtained  and 
recorded  into  an  Excel  spreadsheet  database  using  medical  records  available  (CHCS,  ICDB,  and 
Aviation  Medicine  Clinic  medical  records  available  for  review).  Results  of  each  cadet's  flight  status 
(yes/no)  will  be  requested  from  Aviation  Medicine  Clinic. 

Progress:  Data  anaylsis  completed  and  abstract  sent  to  USPS,  but  not  accepted.  Investigators 
plan  to  review  this  past  summer's  RPTC  EKG  records  to  add  more  numbers  to  the  data. 


302 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203119  Status:  Ongoing 

Title:  Alternating  Antipyretics:  Antipyretic  Efficacy  Of  Acetaminophen  Versus  Acetaminophen 

Alternated  With  Ibuprofen  In  Children 

Principal  Investigator:  CPT  Lynne  C.  Kramer,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Mary  P.  Lairchok,  MC;  COL  (Ret)  Patrick  C.  Kelly,  D.O.;  CPT 

Amy  M.  Thompson,  MC;  CPT  Peaches  A.  Richards,  MC;  CPT  Keith  R.  Compton,  MC;  CPT  David 

P.  Harper,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/27/2004  -  Feb  2004  American  Academy  of  Pediatrics  via  The  8/22/2006 

Geneva  Foundation 

Study  Objective:  To  compare  the  antipyretic  efficacy  of  alternating  ibuprofen  and  acetaminophen 
to  acetaminophen  alone. 

Technical  Approach:  Infants  and  children  6  months  to  6  years  meeting  inclusion  and  exclusion 
criteria  who  present  to  the  pediatric  clinic  with  a  fever  of  100.4  or  greater  will  be  offered 
enrollment  into  the  study.  Baseline  temperature  will  be  recorded  and  initial  dose  of 
acetaminophen  will  be  given.  All  temperature  measurements  will  be  made  using  a  standard  oral  or 
rectal  thermometer  provided  by  the  investigators.  Parents  will  receive  a  handout  and  instruction 
on  facts  and  myths  related  to  fever  and  fever  control  in  children.  Baseline  demographic  data  will 
be  recorded  to  include  age,  sex,  race,  and  underlying  medical  conditions.  Parents  or  caregivers  will 
be  trained  to  take  temperature  with  the  study  thermometer  and  administer  study  medications. 
Subjects  will  be  randomized  via  computer  based  random  number  to  either  the  acetaminophen 
group  or  the  acetaminophen/  ibuprofen  group.  Group  selection  will  be  unblinded  only  to  the  co¬ 
investigator  entering  the  study  medications  into  CHCS.  Study  medications  will  include 
acetaminophen,  ibuprofen,  and  placebos  designed  to  mimic  ibuprofen  and  acetaminophen.  Each 
patient  will  receive  a  study  medication  or  placebo  at  time  zero,  3  hours  and  4  hours. 
Acetaminophen  group  will  receive  acetaminophen  time  zero,  placebo  time  3  hours  and 
acetaminophen  time  4  hours.  Acetaminophen  +  ibuprofen  group  will  receive  acetaminophen  time 
zero,  ibuprofen  time  3  hours  and  placebo  time  4  hours. 

Temperatures  will  be  obtained  and  recorded  from  each  subject  at  0,  3,  4,  5  and  6  hours.  The  study 
will  end  at  6  hours.  All  subjects  will  receive  standard  of  care  for  their  presenting  complaints.  The 
study  will  not  interfere  with  the  evaluation  or  treatment  of  these  complaints.  Once  the  medical 
evaluation  for  the  presenting  complaint  is  complete  subjects  will  be  sent  home  or  admitted 
depending  on  their  medical  condition.  For  subjects  at  home,  the  parent  or  caretaker  will  complete 
the  study.  A  study  investigator  will  contact  the  parent  or  caretaker  at  6  hours  and  obtain  the 
results.  At  the  conclusion  of  the  study  period,  parents  will  read  the  provided  instruction  sheet  on 
what  further  antipyretics  and  antipyretic  schedule  may  be  administered  to  the  child  in  the  case  of 
continuing  fever.  The  information  will  be  provided  as  a  sealed  instruction  sheet  matched  to  the 
randomized  group,  so  that  the  study  investigator  will  remain  blinded. 

Progress:  This  protocol  is  closed  to  enrollment  with  38  subjects  enrolled;  eleven  in  the  last  year. 
Follow-up  is  complete  and  data  analysis  is  underway  with  efforts  to  produce  a  manuscript  by  the 
end  of  August  2006. 


303 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205110 

Status:  Ongoing 

Title:  AALL03N1,  Understanding  the  Ethnic  and  Racial  Differences  in 
with  Acute  Lymphoblastic  Leukemia 

Survival  in  Children 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

11/17/2005  -  May  2008  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

7/10/2006 

Study  Objective:  (1)  To  determine  and  compare  adherence  to  6-MP  in  a  cohort  of  children  with 
ALL  from  four  different  ethnic  and  racial  groups  (Caucasians,  African-Americans,  Hispanics,  and 
Asians)  receiving  maintenance  chemotherapy,  using  the  following  assessments:  serial  red  cell  6- 
MP  metabolites  (6TGN  and  MethylTIMP),  frequency  of  6-MP  dosing  using  an  electronic  pill 
monitoring  system  (MEMS®),  and  self-report  of  adherence  to  6-MP  by  questionnaire.  (2)  To 
determine  the  impact  of  adherence  to  6-MP  (measured  using  6TGN,  MeTIMP,  MEMS®  and  self- 
report  data  independently)  on  event-free- survival  (EFS)  in  the  entire  cohort,  after  adjusting  for 
known  predictors  of  disease  outcome.  (3)  Define  a  critical  level  of  adherence  (measured 
independently  by  6TGN,  MeTIMP,  MEMS®,  self-report)  that  has  a  significant  impact  on  EFS  for 
the  entire  cohort.  (4)  Describe  prevalence  of  adherence  to  6-MP  by  ethnicity  (6TGN,  MeTIMP, 
MEMS®,  Selfreport).  (5)  Describe  behavioral  and  socio-demographic  predictors  of  adherence  using 
the  questionnaire  data.  (6)  Describe  the  pill-taking  practices  in  this  cohort  using  the  MEMS®  data. 
(7)  To  evaluate  the  impact  of  adherence  on  ethnic/racial  difference  in  EFS.  (8)  To  assess  the 
concordance  among  6TGN  and  MeTIMP  levels,  electronic  pill  monitoring,  and  self-reported 
adherence  in  the  ethnic/racial  groups. 

Technical  Approach:  This  study  will  assess  adherence  to  6-MP  in  a  cohort  of  children  with  ALL 
from  four  different  ethnic  and  racial  groups  (Caucasians,  African-Americans,  Hispanics,  and 
Asians),  who  are  receiving  maintenance  chemotherapy,  by  measuring  red  cell  6-MP  metabolites 
(6TGN,  MethylTIMP),  frequency  of  6-MP  dosing  using  an  electronic  pill  monitoring  system 
(MEMS),  and  self/care-giver  report  of  adherence  to  6-MP.  Participants  will  be  asked  to  provide  5 
ml  blood  samples  during  7  time  points  and  complete  an  adherence  questionnaire  at  4  time  points 
during  their  regularly  scheduled  clinic  appointments.  Blood  samples  will  be  used  for  analysis  of 
genetic  polymorphisms  related  to  the  efficacy  of  anti-leukemic  therapy,  and  measurement  of  red 
cell  6TGN/TIMP  levels  (eg.  TPMT).  Participants  will  also  be  given  an  electronic  cap  to  use  with 
their  6-MP  medication  bottle  that  will  record  the  date  and  time  of  bottle  opening.  The  COG 
anticipates  about  720  patients  less  than  or  equal  to  21years  of  age  will  be  participating  in  this 
study.  The  enrollment  for  MAMC  is  estimated  to  be  2-3  patients  per  year. 

Progress:  This  protocol  remains  open  to  enrollment  with  no  patients  enrolled. 


304 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206052  Status:  Ongoing 

Title:  ACNS0331  A  Study  Evaluating  Limited  Target  Volume  Boost  Irradiation  and  Reduced 
Dose  Craniospinal  Radiotherapy  (18.00  Gy)  and  Chemotherapy  in  Children  with  Newly 
Diagnosed  Standard  Risk  Medulloblastoma:  A  Phase  III  Double  Randomized  Trial 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Laucette,  MC;  MAJ  Joseph  P.  Brooks,  MC;  MAJ 
Melissa  A.  Lorouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

3/30/2006  -  Oct  2009  COG/POG  via  The  Geneva  Foundation  N/A 

Study  Objective:  Primary  Objective:  To  determine  whether  reducing  the  craniospinal  dose  of 
radiation  therapy  to  18.00  Gy  in  children  3-7  years  of  age  does  not  compromise  event-free  survival 
and  overall  survival  as  compared  to  treatment  with  23.40  Gy  of  craniospinal  radiation;  and  to 
determine  if  reducing  the  irradiated  volume  of  the  primary  site  tumor  boost  from  the  whole 
posterior  fossa  to  the  tumor  bed  only  will  not  compromise  event-free  and  overall  survival. 

Secondary  Objectives:  To  evaluate  patterns  of  failure  in  children  treated  with  an  irradiation  boost 
volume  smaller  than  conventional  posterior  fossa  volumes.  To  reduce  the  cognitive,  auditory  and 
endocrinologic  effects  of  treatment  of  average-risk  medulloblastoma  by  reducing  the  dose  of 
craniospinal  irradiation  therapy.  To  determine  if  the  audiologic  and  endocrinologic  toxicity  will  be 
reduced  with  the  use  of  limited  tumor  boost  volume  irradiation  compared  to  patients  treated  with 
conventional  target  volumes  of  radiation.  To  develop  an  optimal  gene  expression  medulloblastoma 
outcome  predictor,  validated  prospectively  in  a  multi-institution  randomized  clinical  trial.  To 
improve  compliance  with  long-term  quality  of  life  and  functional  status  data  submission  by 
educating  institutional  nurses  to  administer  and  submit  for  analysis  a  battery  of  four  instruments: 
Behavior  Assessment  System  for  Children  (BASC),  Adaptive  Behavior  Assessment  System 
(ABAS),  Behavior  Rating  Inventory  of  Executive  Function  (Brief),  PedsQLTM  4.0. 

Technical  Approach:  In  order  to  compare  the  effects  of  different  doses  and  volumes  of  radiation, 
children  will  be  randomized  to  radiation  treatment  plans  at  the  time  of  study  entry.  Children  ages 
3  and  less  than  age  8  will  be  randomized  twice.  They  will  be  randomized  between  two  doses  of 
craniospinal  radiation  and  between  a  standard  volume  boost  and  a  smaller  volume  boost.  All 
children  8  years  and  older  will  be  given  the  standard  dose  of  craniospinal  radiation  and  will  only 
be  randomized  for  the  boost  volume  of  radiation.  Chemoradiotherapy  begins  about  4  weeks  after 
surgery.  Radiation  therapy  to  the  brain  and  spine  will  be  given  5  days  each  week  for  6  weeks. 
Vincristine  will  be  given  IV  push  once  a  week  for  6  weeks  beginning  at  Week  1  (one  week  after  the 
start  of  radiation).  Maintenance  Chemotherapy  begins  4  weeks  after  the  completion  of 
chemoradiotherapy.  There  will  be  9  cycles  of  maintenance;  two  different  kinds  of  cycles  given. 
Cycle  A  lasts  for  6  weeks  and  Cycle  B  for  4  weeks  (given  after  the  completion  of  2  A  cycles). 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled  during  FY06. 


305 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206095 

Status:  Ongoing 

Title:  AEWS02B1,  A  Group  wide  Biology  and  Banking  Study  for  Ewing  Sarcoma 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

7/26/2006  -  May  2016  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Objectives:  (1)  To  develop  a  mechanism  to  collect  and  distribute  tumor 
specimens  to  various  investigators,  and  a  system  to  prioritize  and  develop  quality-control 
measures  for  central  data  reporting  of  studies  undertaken.  (2)  To  determine  the  prognostic 
significance  of  translocation  subtype  in  Ewing  sarcoma;  to  determine  the  prognostic  significance  of 
translocation  negative  Ewing  sarcoma.  (3)  To  determine  the  prognostic  significance  of  MRD 
detection  in  bone  marrow  specimens  by  RT-PCR  determination  of  EWS-ETS  fusion  genes.  (3)  To 
determine  whether  serum  levels  of  IGF1,  IGFBP3  are  of  significance  in  the  outcome  of  patients 
with  Ewing  sarcoma.  (4)  To  determine  whether  RNA  expression  profiles  performed  on  diagnostic 
specimens  will  allow  for  the  identification  of  newer  prognostic  categories  and  potentially  new 
molecular  targets  for  treatment  in  Ewing  sarcoma.  (5)  To  identify  new  treatment  targets  for 
therapy.  Further  testing  of  these  potential  targets  will  be  carried  out  in  hopes  of  expediting 
translation  of  these  findings  to  the  clinic.  (6)  To  establish  a  bank  of  Ewing  sarcoma  xenografts  in 
SCID/Beige  mice.  (7)  To  establish  clinical  proteomics  as  a  resource  for  investigations  of  altered 
signaling  molecules  in  the  pathogenesis  of  Ewing  sarcoma. 

Technical  Approach:  Study  AEWS02B1  is  a  biology  and  banking  study  for  Ewing  Sarcoma 
designed  to  analyze  biological  factors  of  Ewing's  tumors  and  relate  tumor  characteristics  to 
treatment  outcomes.  At  initial  diagnosis  extra  tumor  specimens  will  be  sent  to  the  Children's 
Oncology  Group  (paraffin  blocks  or  unstained  slides  and  thick  sections,  blood,  bone  marrow, 
serum,  fresh  sterile  tumor  frozen  in  OCT  media,  and  fresh  sterile  tumor  in  RPMI).  Pathologists 
are  encouraged  to  submit  additional  tumor  tissue  obtained  at  the  time  of  later  biopsies  or  surgical 
procedures  to  document  response,  recurrence,  or  progressive  disease,  and  tissue  obtained  at 
autopsy.  Enrollment  for  MAMC  is  estimated  to  be  1-2  patients  per  year. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  no  patients  enrolled. 


306 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206096 

Status:  Ongoing 

Title:  AHOD0431,  A  Phase  III  Study  for  the  Treatment  of  Children  and  Adolescents  with  Newly 
Diagnosed  Low  Risk  Hodgkin  Disease 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

8/11/2006  -  Feb  2009  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Objectives:  (1)  To  investigate  the  paradigm  of  response-based  therapy  for  low 
risk  Hodgkin  disease  by  eliminating  involved-field  radiation  therapy  (IFRT)  for  subjects  who 
achieve  a  CR  with  initial  chemotherapy.  (2)  To  investigate  whether  three  cycles  of  AV-PC*  for  the 
treatment  of  low  risk  Hodgkin  disease  is  sufficient  to  induce  CR  in  at  least  80%  of  subjects.  (3)  To 
investigate  whether  subjects  who  experience  a  low  risk  relapse  after  initial  treatment  with 
chemotherapy  alone  can  be  successfully  treated  with  a  salvage  regimen  consisting  of  IV/DECA  and 
IFRT.  (3)  To  maintain  the  overall  survival  (OS)  for  subjects  with  low  risk  Hodgkin  disease  at  or 
above  97%.  (4)  To  determine  the  prognostic  significance  of  very  early  response  as  measured  by 
FDG-PET  or  gallium  after  the  first  course  of  chemotherapy.  (5)  To  evaluate  the  prognostic 
significance  of  elevation  of  ESR  and  CRP  at  the  time  of  diagnosis  in  low  risk  Hodgkin  disease  on 
CR  rate  and  relapse  rate  after  chemotherapy  alone.  (6)  To  determine  the  frequency  and  severity  of 
late  effects  of  therapy  including  thyroid  dysfunction,  infertility,  cardiotoxicity  and  second 
malignant  neoplasms. 

Technical  Approach:  All  patients  will  have  initial  treatment  utilizing  AV-PC*  with  or  without 
involved  field  radiation  therapy.  Those  patients  who  are  in  complete  remission  after  three  cycles  of 
AV-PC*  will  begin  follow-up.  Those  patients  who  are  in  partial  remission  after  three  cycles  will 
receive  involved  field  radiation  therapy.  Those  who  fail  to  achieve  a  partial  remission  with  initial 
chemotherapy,  who  have  progressive  disease  prior  to  completing  initial  therapy,  or  who  fail  to 
achieve  a  complete  remission  after  radiation  therapy  will  be  off  study.  All  patients  with  a  positive 
FDG-PET  (or  gallium)  prior  to  initiating  treatment  will  have  a  second  scan  after  one  course  of  AV- 
PC*  utilizing  the  same  modality  as  the  initial  scan  (FDG-PET  strongly  encouraged  if  available). 
Those  with  a  persistently  positive  study  will  have  a  third  scan  after  chemotherapy  to  document 
remission  status.  Patients  who  experience  a  biopsy  proven  low  risk  recurrence  after  achieving  a 
complete  remission  with  chemotherapy  alone  will  be  treated  with  a  salvage  regimen.  The  initial 
treatment  will  consist  of  3  cycles  of  AV-PC*.  Each  cycle  is  21  days  in  duration  and  commences  on 
Day  1  if  the  ANC  >  750  (with  patients  off  G-CSF  for  at  least  2  days)  and  platelets  are  >  75,000. 
Subjects  in  complete  remission  after  three  courses  of  initial  chemotherapy  will  stop  treatment  and 
begin  follow-up.  Subjects  with  partial  remission  after  three  courses  of  initial  chemotherapy  will 
proceed  to  involved  field  radiation  therapy.  Radiation  therapy  will  commence  approximately  4 
weeks  after  the  3rd  cycle  of  AV-PC*  is  completed  and  when  ANC  >1000  and  platelet  count 
>100,000.  Patients  who  experience  a  biopsy  proven  low  risk  relapse  after  achieving  a  complete 
remission  with  chemotherapy  alone  at  initial  treatment,  and  therefore  have  not  had  prior 
radiation  therapy,  will  be  treated  with  two  cycles  of  Ifosfamide  and  Vinorelbine,  followed  by  two 
cycles  of  Dexamethasone,  Etoposide,  Cisplatin,  ARA-C  followed  by  involved  field  radiation  therapy. 
Each  cycle  will  be  21  days  in  length.  All  relapses  must  be  biopsy  proven.  All  patients  on  the 
salvage  regimen  will  proceed  to  involved  field  radiation  therapy  after  four  cycles  of  salvage 
chemotherapy.  Radiation  therapy  will  commence  approximately  4  weeks  after  the  2nd  cycle  of 
DECA  is  completed  and  when  ANC  >1000  and  platelet  count  >100,000. 

Progress:  This  protocol  remains  open  to  patient  entry,  with  no  patients  enrolled. 


307 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206051 

Status:  Ongoing 

Title:  ANBL0032  Phase  III  Randomized  Study  Of  Chimeric  Antibody  14.18  (Chl4.18)  In  High 
Risk  Neuroblastoma  Following  Myeloablative  Therapy  And  Autologous  Stem  Cell  Rescue 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

4/6/2006  -  Oct  2006  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  Primary  objective  to  determine  if  monoclonal  antibody  Chl4.18  +  cytokines  + 
isotretinoin  (13-cis-retinoic  acid,  or  RA)  improves  event  free  survival  after  myeloablative  therapy 
and  stem  cell  rescue  as  compared  to  RA  alone,  in  high  risk  neuroblastoma  patients  who  have 
achieved  a  pre-ASCT  response  of  CR,  VGPR,  or  PR. 

Secondary  objectives:  (1)  to  determine  if  monoclonal  antibody  Chl4.18  +  cytokines  +  isotretinoin 
(13-cis-retinoic  acid,  or  RA)  improves  overall  survival  after  myeloablative  therapy  and  stem  cell 
rescue  as  compared  to  RA  alone,  in  high  risk  neuroblastoma  patients  who  have  achieved  a  pre- 
ASCT  response  of  CR,  VGPR,  or  PR.  (2)  Determine  if  immunotherapy  +  RA  improve  event  free 
survival  and  overall  survival  as  compared  to  RA  alone,  in  the  subgroup  of  high  risk  INSS  stage  4 
neuroblastoma  patients  who  have  achieved  a  pre-ASCT  response  of  CR,  VGPR,  or  PR.  (3)  To 
determine  the  variability  of  13-cis-retinoic-acid  pharmacokinetics  and  relationship  to 
pharmacogenomic  parameters  and  determine  if  these  levels  and/or  genetic  variations  correlate 
with  EFS  or  systemic  toxicity.  (4)  In  the  subgroup  of  neuroblastoma  patients  who  have  achieved  a 
pre-ASCT  response  of  CR,  VGPR,  or  PR,  determine  if  there  is  a  difference  between  the  two 
randomized  regimens  in  reducing  the  minimal  residual  disease  (MRD)  burden  as  detected  by  the 
following  parameters:  meta-iodobenylguanidine  (MIBG)  scan,  immunocytology  (IC)  of  blood  and 
bone  marrow  samples,  RT-PCR  for  tyrosine  hydroxylase,  PGP  9.5,  and  MAGE-1  in  blood  and  bone 
marrow.  (5)  Determine  if  change  from  baseline  of  MRD  as  measured  by  above  parameters  is 
associated  with  event  free  and  overall  survival.  (6)  Determine  whether  tumor  biology  at  diagnosis 
correlates  with  event-free  and  overall  survival,  for  either  of  the  randomized  regimens.  (7) 
Determine  the  toxicities  of  the  combination  of  monoclonal  Chl4.18  with  cytokines.  (8)  To  explore 
the  relationship  between  antibody-dependent  cellular  cytotoxicity  (ADCC)  and  EFS.  (9)  To 
determine  a  descriptive  profile  of  human  anti-chimeric  antibody  (HACA)  during  immunotherapy. 
(10)  To  compare  the  outcome  data  of  the  patients  with  persistent  disease  documented  by  biopsy 
(stratum  07)  to  the  historical  data  for  the  analogous  patients  from  CCG-3981. 

Technical  Approach:  Patients  will  be  enrolled  and  randomized  into  regimen  A  or  B  on  day  50 
post-ASCT,  up  to  day  77  (see  special  exemption)  post-ASCT  when  1)  total  absolute  phagocyte  count 
(APC)  is  at  least  1000/?L  2)  organ  functions  have  met  the  eligibility  criteria,  and,  3)  tumor 
assessment  has  been  completed  following  the  end  of  radiotherapy  at  least  5  days  before. 
Randomization  will  be  stratified  by  pre-ASCT  CR  versus  VGPR  versus  PR  and  by  purging  vs. 
nonpurging  of  the  stem  cells  for  ASCT.  Regimen  A  consists  of  oral  intake  of  isotretinoin  (13-cis- 
retinoic  acid,  or  RA)  starting  day  66  post-ASCT  at  80  mg/m2/dose  twice  a  day  for  14  days  every  28 
days,  for  6  courses.  For  regimen  B,  patients  will  receive  oral  isotretinoin  (13-cis-retinoic  acid,  or 
RA)  as  in  regimen  A.  In  addition,  patients  will  receive  5  courses  of  chl4.18  +  cytokines,  with 
chl4.18  +  GM-CSF  administered  in  courses  1,  3,  and  5,  and  chl4.18  +  aldesleukin  (IL-2)  given  in 
courses  2  and  4.  The  intervals  between  antibody  administrations  are  28  days  for  all  courses. 

Progress:  This  protocol  is  open  to  patient  entry,  with  no  patients  enrolled  during  FY06. 


308 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206097 

Status:  Ongoing 

Title:  AREN03B2;  Renal  Tumors  Classification,  Biology,  and  Banking  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

7/26/2006  -  Indef  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  To  classify  patients  with  renal  tumors  by  histological  categorization,  surgical- 
pathological  stage,  presence  of  metastases,  age  at  diagnosis,  tumor  weight  and  loss  of 
heterozygosity  for  chromosomes  lp  and  16q,  to  thereby  define  eligibility  for  a  series  of  therapeutic 
studies.  To  maintain  a  biological  samples  bank  to  make  specimens  available  to  scientists  to 
evaluate  additional  potential  biological  prognostic  variables  and  for  the  conduct  of  other  research 
by  scientists. 

Technical  Approach:  This  classification  protocol  will  provide  the  mechanism  to  identify  renal 
tumor  patients  on  a  population  basis,  and  to  describe  their  characteristics  at  diagnosis.  This  study 
will  also  establish  the  natural  history  (relapse-free  and  overall  survival)  for  patients  with  disease 
for  which  there  will  not  be  a  therapeutic  or  outcomes  study  (all  renal  tumors  except  Wilms, 
rhabdoid,  clear  cell  sarcoma,  and  renal  cell  carcinoma).  These  cases,  after  central  review  results 
are  reported  back  to  the  enrolling  Institution,  will  be  followed  (date  of  last  follow-up,  relapse,  and 
death)  as  part  of  their  enrollment  on  AREN03B2.  It  is  expected  that  all  such  patients,  even  with 
benign  tumor,  will  be  followed  at  least  yearly,  for  a  period  of  about  ten  years,  by  the  enrolling 
Institution  (at  the  time  of  enrollment,  institutions  will  be  notified  which  cases  must  be  followed). 
Patients  less  than  30  years  of  age  will  be  participating  in  this  study.  The  enrollment  for  MAMC  is 
estimated  to  be  1-2  patients  per  year. 

Progress:  This  protocol  is  open  to  patient  entry,  with  one  patient  enrolled  at  MAMC  during  FY06. 


309 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  200032 

Status:  Completed 

Title:  COG  9900,  ALinC  17,  Classification  (C),  B-Precursor  Induction  Treatment  (I)  Protocol 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

1/25/2000  -  Jan  2005  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

12/8/2005 

Study  Objective:  (1)  To  provide  the  clinical  and  laboratory  data  necessary  for  placing  each 
patient  with  ALL  onto  proper  therapeutic  trial,  and  (2)  to  provide  an  administrative  base  to 
capture  classification  data  for  correlative  studies  in  ALL  treatment  protocols  and  series  of 
historical  protocols. 

Technical  Approach:  At  the  time  of  diagnostic  evaluation  which  includes  bone  marrow 
aspiration  and/or  biopsy,  20  ml  of  bone  marrow  and  25  ml  of  peripheral  blood  will  be  collected  and 
processed  for  local  laboratory  studies  and  submission  to  the  following  POG  reference  laboratories: 
1.  Johns  Hopkins  University  for  Immunophenotyping.  2.  University  of  New  Mexico  (UNM)  for 
DNA  Index,  FISH,  Molecular  testing,  Cell  banking.  3.  Medical  College  of  Wisconsin  for 
Glucocorticoid  receptors.  4.  University  of  Texas  Southwestern  Medical  Center  for  Homocysteine 
Children's  Hospital  of  Michigan  for  Drug  sensitivity  profiles.  5.  MUSC  -  Children's  Hospital  for 
Drug  sensitivity  profiles.  UCSD  Medical  Center  for  Tumor  suppressor  gene  studies.  The  data 
captured  on  this  protocol  will  be  used  in  the  therapeutic  trials,  in  cross  era  analysis,  and  in 
international  collaborations  to  further  define  the  prognostic  importance  of  biologic  features  in 
ALL. 

Progress:  This  protocol  was  reported  as  completed  in  August  2006,  with  eleven  patients  enrolled 
at  MAMC,  none  during  FY06.  One  patient  is  deceased  and  the  other  ten  patients  will  continue  to 
be  followed  under  their  therapeutic  protocols. 


310 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  200077 

Status:  Ongoing 

Title:  COG  9904,  ALinC  17:  Treatment  for  Patients  with  Low  Risk  Acute  Lymphoblastic 
Leukemia,  A  Phase  III  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

5/12/2000  -  May  2004  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

4/25/2006 

Study  Objective:  (1)  In  conjunction  with  POG  9905,  to  compare  short  MTX  infusion  (2g/m2  over  4 
hours)  with  a  longer  infusion  (lg/m2  over  24  hours),  primarily  with  respect  to  efficacy  and 
secondarily  with  respect  to  toxicity.  (2)  to  determine  in  a  randomized  trial,  if  a  delayed  multi- drug 
intensification,  administered  in  the  context  of  intensive  anti-metabolite  therapy,  will  improve 
outcome  for  children  with  ALL,  (3)  To  determine  the  correlation  between  peripheral  blood  and  CSF 
concentrations  of  homocysteine  and  its  metabolites  and  acute  (seizures)  and  chronic  neurotoxicity 
(neurocognitive  dysfunction),  and  (4)  To  determine  the  relationship  between  a  membrane  bound 
glucocorticoid  receptor  and  EFS  via  quantitation  of  the  glucocorticoid  receptor  concentrations  in 
marrow  samples  at  diagnosis. 

Technical  Approach:  This  protocol  will  randomize  between  the  4-hour  and  24  hour  methotrexate 
infusion  and  for  patients  with  TEL/AML1  gene,  between  standard  and  delayed  intensification. 

Data  from  POG  9904  and  9905  will  be  pooled  for  statistical  analysis  of  efficacy  and  toxicity.  This 
study  will  determine  the  correlation  between  peripheral  blood  and  CSF  concentrations  of 
homocysteine  and  its  metabolites  and  acute  (seizures)  and  chronic  neurotoxicity  (neurocognitive 
dysfunction).  Induction  will  include  three  or  four  drugs  (dependent  on  initial  risk  classification 
POG  9900). 

Progress:  This  protocol  closed  to  patient  entry  in  April  2005,  with  four  patients  enrolled.  One 
patient  remains  on  treatment  and  three  patients  have  completed  study  treatment;  all  continued  to 
be  followed  at  MAMC  during  FY06. 


311 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200139  Status:  Ongoing 

Title:  COG  A5971:  Randomized  Phase  III  Study  for  the  Treatment  of  Newly  Diagnosed 
Disseminated  Lymphoblastic  Lymphoma  or  Localized  Lymphoblastic  Lymphoma,  A  Phase  III 
COG  Study 


Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

9/26/2000  -  Sep  2007  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

8/24/2006 

Study  Objective:  (1)  To  compare  the  event  free  survival  and  survival  in  patients  with 
disseminated  lymphoblastic  lymphoma  treated  on  four  regimens.  (NHL/BFM-95  vs.  CCG  BFM),  (2) 
To  determine  if  treatment  with  a  regimen  without  high  dose  methotrexate  will  maintain  the  same 
excellent  disease  free  survival  obtained  with  NHL/BFM-90,  (3)  To  determine  if  intensification 
with  anthracycline  and  cyclophosphamide  improves  disease  free  survival,  (4)  To  collect  outcome 
data  on  uniformly  treated  patients  with  localized  disease  or  CNS  positive  disease,  and  (5)  To 
determine  if  rapid  reduction  in  tumor  volume  as  defined  by  chest  radiography  and  CT  is  predictive 
of  improved  outcome. 

Technical  Approach:  Patients  with  disseminated  (Murphy  stage  III  or  IV)  lymphoblastic 
lymphoma  without  evidence  of  CNS  disease  will  be  randomized  to  one  of  four  treatment  regimens: 
Standard  CCG  BFM  (regimen  Al);  CCG  BFM  intensified  with  cyclophosphamide/anthracycline 
intensification  during  the  induction  and  delayed  intensification  phases  (regimen  A2);  Standard 
NHL/BFM-95  (regimen  BI);  or  NHL/BFM-95  intensified  with  cyclophosphamide/anthracycline 
intensification  during  the  induction  and  delayed  intensification  phases  (regimen  B2).  Patients  with 
disseminated  lymphoblastic  lymphoma  positive  for  CNS  disease  will  be  assigned  to  the  intensified 
NHL/BFM-95  arm  (regimen  B2)  with  delayed  radiation  therapy.  Patients  with  localized 
lymphoblastic  lymphoma  (Murphy  stage  I  or  II)  will  be  assigned  to  the  standard  CCG  BFM  arm 
without  additional  intrathecal  methotrexate  (regimen  AO).  The  duration  of  each  treatment  arm  is 
2  years  and  consists  of  Induction,  Consolidation,  Interim  Maintenance,  Delayed  Intensification, 
and  Maintenance  therapies. 

Progress:  COG  temporarily  closed  accrual  to  this  protocol  in  September  2005,  to  assess  whether 
the  number  of  evaluable  patients  was  sufficient  to  answer  the  study  question.  Madigan  had 
enrolled  one  patient  in  2004,  who  is  currently  being  treated  at  WRAMC,  although  MAMC 
continues  to  be  responsible  for  data  submission  to  COG.  COG  lifted  the  temporary  suspension  and 
the  protocol  was  approved  by  the  IRB  to  continue  patient  enrollment  at  MAMC  on  26  September 
2006. 


312 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205015 

Status:  Ongoing 

Title:  COG  AALL0031,  A  COG  Pilot  Study  for  the  Treatment  of  Very  High  Risk  Acute 
Lymphoblastic  Leukemia  in  Children  and  Adolescents 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

4/5/2005  -  Jun  2005  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

10/24/2006 

Study  Objective:  Primary  Objective:  To  determine  the  feasibility  in  terms  of  patient  accrual  and 
toxicity  of  an  intensified  chemotherapeutic  regimen  incorporating  novel  agents  for  treatment  of 
children  and  adolescents  with  very  high  risk  (VHR)  ALL.  Secondary  Objectives:  (1)  To  determine  if 
the  BCR-ABL-specific  tyrosine  kinase  inhibitor  STI571  can  be  incorporated  into  this  regimen  with 
acceptable  toxicity  for  patients  with  Ph+  ALL.  (2)  To  compare  EFS  for  VHR  patients  treated  with 
the  intensive  chemotherapy  with  that  of  historical  controls.  (3)  To  conduct  a  preliminary 
evaluation  of  the  feasibility  and  efficacy  of  following  intensive  consolidation  by  Hematopoietic 
Stem  Cell  Transplantation  (HSCT)  as  therapy  for  patients  with  HLA  matched  related  donors.  (4) 
To  determine  if  MRD  assessed  at  the  end  of  induction  and  prior  to  reinductioin  and  prior  to  HSCT 
therapy  by  PCR  and  flow  cytometry  can  predict  elapse.  (5)  To  evaluate  whether  MRD  detected  by 
PCR  at  post-intensification  time  points  is  prognostically  significant.  (6)  To  evaluate  whether  gene 
expression  patterns  can  be  identified  by  microarray  evaluations  to  predict  disease  recurrence  or 
response  to  STI571. 

Technical  Approach:  This  pilot  study  will  utilize  a  novel  intensified  chemotherapeutic  regimen 
for  VHR  patients  based  on  (1)  the  use  of  ifosfamide  and  etoposide  in  POG  ALL  relapse  studies;  (2) 
the  use  of  high  dose  methotrexate  for  children  and  infants;  and  (3)  the  intensive  CCG  New  York  II 
regimen  used  for  patients  with  lymphomatous  ALL.  The  study  will  determine  whether  an 
adequate  number  of  VHR  patients  will  be  accrued  to  form  the  basis  for  development  of  a  future 
phase  III  trial  within  the  COG.  The  presence  or  absence  of  minimal  residual  disease  in  patients  in 
remission  also  will  be  determined.  If  the  intensive  treatment  is  found  to  have  acceptable  toxicity 
and  shows  potential,  either  alone,  or  with  transplant,  for  improving  outcome  of  the  VHR  patient 
population,  it  will  be  the  first  promising  strategy  identified  for  this  group.  The  accrual  goal  is  110 
patients  over  a  2  year  time  frame. 

Progress:  This  protocol  closed  to  accrual  in  October  2006.  MAMC  enrolled  one  patient  enrolled 
who  continued  to  be  followed  during  FY06.  The  patient  is  no  longer  receiving  study  treatment. 


313 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205068  Status:  Ongoing 

Title:  COG  AALL0232,  High  Risk  B-precursor  Acute  Lymphoblastic  Leukemia 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/29/2005  -  Mar  2015  COG/POG  via  The  Geneva  Foundation  5/23/2006 

Study  Objective:  (1)  To  improve  the  outcome  of  children  with  high  risk  acute  lymphoblastic 
leukemia.  (2)  To  determine  the  relative  safety  and  efficacy  of  dexamethasone  given  for  14  days 
versus  prednisone  given  for  28  days  during  Induction.  (3)  To  determine  the  relative  safety  and 
efficacy  of  high  dose  methotrexate  (5gm/m2)  with  Leucovorin  rescue  compared  to  escalating 
methotrexate  without  Leucovorin  rescue  (Capizzi  I)  delivered  during  Interim  Maintenance.  (4)  To 
correlate  Day  29  Minimal  Residual  Disease  (MRD)  with  Event  Free  Survival  (EFS)  and  Overall 
Survival  (OS).  (5)  To  correlate  early  marrow  response  status  with  Day  29  MRD  status.  (6)  To 
improve  outcome  by  identifying  additional  high  risk  patients  by  day  29  MRD  for  treatment  with 
fully  augmented  BFM. 

Technical  Approach:  This  study  will  compare  the  use  of  two  steroid  drugs,  dexamethasone  and 
prednisone,  during  induction  and  will  examine  the  best  way  to  give  methotrexate  during  the 
interim  maintenance  phase  of  treatment.  This  study  will  use  a  known  chemotherapy  regimen  that 
has  been  very  effective  for  treating  children  with  high  risk  ALL  and  test  whether  two  changes  to 
this  treatment  can  cure  more  patients  without  increasing  side  effects.  The  aim  of  the  first  change 
is  to  test  whether  14  days  of  dexamethasone  is  tolerated  without  an  increased  number  of  severe 
side  effects  and  is  better  than  28  days  of  prednisone  in  decreasing  the  number  of  leukemia  cells 
during  the  first  month  of  treatment.  The  aim  of  the  second  change  is  to  determine  whether  giving 
higher  doses  of  methotrexate,  during  interim  maintenance,  will  work  better  than  giving  it  on  a 
schedule  that  starts  with  a  lower  dose  and  increases  with  each  of  the  later  doses. 

Progress:  This  protocol  remains  open  to  enrollment  with  two  patients  enrolled  at  MAMC,  1 
during  FY06.  Two  patients  received  study  treatment.  One  patient  was  an  induction  failure,  was 
taken  off  study  and  enrolled  onto  another  COG  protocol. 


314 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205095  Status:  Ongoing 

Title:  COG  AALL0331,  Standard  Risk  B-precursor  Acute  Lymphoblastic  Leukemia;  A  Phase  III 

Group-Wide  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/15/2005  -  July  2009  COG/POG  via  The  Geneva  Foundation  6/27/2006 

Study  Objective:  (1)  To  determine  whether  the  substitution  of  three  intensified  phases  of  post¬ 
induction  treatment  for  standard  phases  will  improve  the  event  free  survival  (EFS)  of  children 
with  SR-average  acute  lymphoblastic  leukemia  (ALL).  (2)  To  determine  whether  the  addition  of 
four  doses  of  PEG  Asparaginase,  given  once  every  three  weeks  during  consolidation  and  interim 
maintenance  phases,  will  improve  the  EFS  for  children  with  SR-low  ALL.  (3)  To  identify 
potentially  modifiable  factors  associated  with  impaired  health  related  quality  of  life  (HRQOL)  at 
different  periods  of  therapy  in  the  patients  who  are  SR-average  enrolled  on  the  standard  risk  ALL 
study.  (4)  To  determine  the  critical  time  periods  when  future  intervention  studies  to  mitigate 
adverse  HRQOL  outcomes  should  occur.  (5)  To  correlate  Day  29  Minimal  Residual  Disease  (MRD) 
with  EFS  and  Overall  Survival  (OS).  (6)  To  correlate  early  marrow  response  status  with  Day  29 
MRD  status.  (7)  To  improve  outcome  by  identifying  additional  high  risk  patients  by  Day  29  MRD 
for  treatment  with  fully  augmented  BFM.  (8)  To  examine  the  relative  contributions  of  genetic 
factors  and  early  treatment  response  to  outcome  by  comparing  the  outcome  of  patients  with  and 
without  TEL-AML1  fusion  or  triple  trisomy  and  low  levels  of  MRD  at  end  Induction  who  are 
treated  with  identical  therapy  on  the  standard  arms  of  the  SR-low  and  SR-average  trials. 

Technical  Approach:  Patients  treated  on  this  study  will  receive  multiple  drugs  all  designed  to 
kill  leukemia  cells.  Patients  who  have  an  appropriate  donor  will  be  given  a  blood  and  marrow 
transplant.  Those  without  an  appropriate  donor  will  continue  on  with  more  chemotherapy. 
Patients  with  high  levels  of  cancer  cells  in  the  spinal  fluid  will  also  receive  radiation  to  the  brain. 
Boys  with  leukemia  cells  in  the  testes  will  receive  radiation  to  the  testes.  Patients  receiving  a 
blood  and  marrow  transplant  will  also  be  given  radiation  to  the  entire  body  before  their  transplant 
and  will  be  hospitalized  for  about  three  months  during  treatment.  The  new  drug  for  patients  with 
leukemia  containing  the  Philadelphia  chromosome  positive  (Ph+)  is  called  Imatinib  (STI571),  and 
it  is  given  throughout  treatment.  If  a  patient  goes  on  to  have  a  blood  and  marrow  transplant, 
Imatinib  (STI571)  may  be  given  after  the  transplant  at  the  transplant  center  or  at  the  primary 
care  center 

Progress:  This  protocol  remains  open  to  enrollment  with  one  patient  enrolled  during  FY06  and 
continuing  to  receive  treatment. 


315 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205067  Status:  Ongoing 

Title:  COG  AALL03B1,  Classification  of  Acute  Lymphoblastic  Leukemia 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/11/2005  -  Mar  2015  COG/POG  via  The  Geneva  Foundation  4/25/2006 

Study  Objective:  To  provide  a  classification  guide  that  will  organize  the  clinical  and  laboratory 
data  necessary  for  assigning  each  patient  with  newly  diagnosed  ALL  to  a  specific  therapeutic  trial. 
(2)  To  provide  an  administrative  base  to  capture  classification  data  for  correlative  studies 
accompanying  current  Children's  Oncology  Group  (COG)  ALL  treatment  protocols.  (3)  To  provide  a 
central  reference  guide  for  all  required  and  research  only  studies  that  will  be  conducted  at  local 
and  reference  laboratories  for  all  newly  diagnosed  patients  with  ALL.  (4)  To  provide  a  mechanism 
for  optional  banking  of  leukemia  and  germ  line  specimens  for  current  and  future  research. 

Technical  Approach:  This  COG  risk  group  classification  protocol  will  serve  as  a  foundation  for 
patients  with  newly  diagnosed  ALL.  Registration  on  this  protocol  will  be  a  requirement  for  entry 
onto  any  COG  therapeutic  study.  The  purpose  of  this  classification  protocol  for  ALL  is  to  integrate 
data  from  recently  completed  clinical  trials  into  an  organized  framework  to  appropriately  risk 
stratify  and  treat  patients  enrolled  in  COG  clinical  trials  for  ALL.  Patients  will  be  assigned  to  an 
induction  treatment  regimen  on  the  basis  of  studies  that  are  performed  at  the  host  institution. 
Additional  samples  will  also  be  sent  by  the  local  institution  to  one  or  more  COG  ALL  reference 
labs  at  the  time  of  diagnosis  and  at  defined  time  points  during  therapy.  This  data  will  be  used  to 
refine  subsequent  therapy  at  the  end  of  induction  by  assignment  to  a  specific  treatment  protocol 
for  defined  risk  groups  in  non-infant  B-precursor  ALL  and/or  via  non-randomized  allocation  to 
specific  treatment  regimens  within  a  given  trial.  The  classification  study  will  also  be  used  for 
participation  in  companion  biology  research  studies  that  are  not  used  for  treatment  allocation  and 
for  voluntary  banking  of  leukemia  cells  for  future  research.  Approximately  8000  people  will  take 
part  in  this  study  across  the  United  States  and  abroad.  Madigan  Army  Medical  Center  plans  to 
enroll  2-3  patients  per  year. 

Progress:  This  protocol  remains  open  to  enrollment  with  three  patients  enrolled  at  MAMC,  2 
during  FY06.  All  three  patients  have  been  enrolled  in  treatment  studies  and  are  currently 
receiving  treatment. 


316 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205026  Status:  Completed 

Title:  COG  AAML03P1,  Treatment  of  Newly  Diagnosed  Childhood  Acute  Myeloid  Leukemia 
(AML)  Using  Intensive  MRC-Based  Therapy  and  Gemtuzumab  Ozogamicin  (GMTZ):  A  COG 
Pilot  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 


Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion: 

3/16/2005  -  Jan  2006 

Funding: 

COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

N/A 

Study  Objective:  To  determine  the  safety  of  adding  a  single  dose  of  gemtuzumab  ozogamicin 
(GMTZ)  to  a  well  established  intensive  two-course  MRC-based  regimen  (Medical  Research  Council) 
for  remission  Induction  of  children  with  newly  diagnosed  AML.  (2)  To  determine  the  complete 
remission  rate  of  a  remission  Induction  regimen  that  consists  of  two  consecutive  courses  of 
cytarabine,  daunorubicin,  and  etoposide  (ADE)  plus  a  single  dose  of  GMTZ  in  the  initial  course  of 
ADE.  (3)  To  determine  the  safety  of  adding  a  single  dose  of  GMTZ  to  one  course  of  post-remission 
Intensification  therapy  for  children  with  newly  diagnosed  AML.  (4)  To  determine  the  feasibility  of 
performing  biological  studies  (FLT3-ITD,  MRD)  for  risk  group  stratification.  (5)  Feasibility 
component  with  the  following  objective:  To  determine  the  proportion  of  AML  patients  with  primary 
induction  failure  (PIF)  for  whom  a  suitable  unrelated  stem  cell  donor  can  be  made  available  within 
21  days  of  study  entry,  and,  identify  obstacles  to  rapid  donor  identification.. 

Technical  Approach:  This  study  combines  GMTZ  with  standard  chemotherapy  and  consists  of 
four  phases.  Patients  with  <20%  blasts  at  the  end  of  phase  I  (Induction  I)  receive  phase  II  ADE. 
Patients  in  complete  remission  at  the  end  of  phase  II  (Induction  II)  proceed  to  phase  III  AE 
(Intensification  #1).  Patients  with  matched  family  donors  who  complete  Intensification  #1  and  who 
remain  in  remission  will  be  assigned  to  receive  allogeneic  BMT.  Patients  without  matched  family 
donors  who  complete  Intensification  #1  and  who  remain  in  remission  will  be  assigned 
chemotherapy  (MA+GMTZ  followed  by  Capizzi  II).  This  study  will  stop  accruing  when  150  patients 
have  been  evaluated.  This  accrual  goal  should  be  met  in  less  than  a  year. 

Progress:  COG  reported  accrual  goals  reached  as  of  1  November  2005;  no  subjects  enrolled  at 
MAMC. 


317 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205122 

Status:  Completed 

Title:  COG  ACNS0126,  A  Phase  II  Study  of  Temozolomide  in  the  Treatment  of  Children  with 
High-grade  Glioma  or  diffuse  intrinsic  Pontine  Gliomas 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

8/22/2005  -  Oct  2006  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

7/18/2006 

Study  Objective:  (1)  To  determine  whether  temozolomide  given  during  radiation  therapy  and  as 
adjuvant  therapy  results  in  an  improvement  in  event-free  survival  compared  to  historical  control 
cohorts.  Target  tumors  are:  Anaplastic  Astrocytoma,  Glioblastoma  Multiforme,  Gliosarcoma  and 
Diffuse  Intrinsic  Pontine  Gliomas.  (2)  To  further  assess  the  toxicity  of  temozolomide  in  a  larger 
group  of  patients  treated  during  XRT  and  during  adjuvant  treatment.  (3)  To  evaluate  the  efficacy 
of  temozolomide  in  the  treatment  of  children  with  diffuse  intrinsic  Pontine  gliomas.  (4)  To  monitor 
the  toxicity  of  this  therapy  in  the  treatment  of  children  with  diffuse  intrinsic  pontine  gliomas. 
Laboratory  Correlates  (HGG  Patients  Only):  (1)  Investigate  MGMT  expression  in  formalin-fixed, 
paraffin-embedded  biopsy  specimens  of  brain  tumors  using  immunohistochemical  methods.  (2) 
Identify  those  tumors  in  which  MGMT  expression  is  silenced  by  determining  promoter  CpG 
methylation  in  DNA  isolated  from  formalin-fixed,  paraffin-embedded  tumor  samples.  (3) 
Investigate  whether  a  functional  MMR  system  is  present  in  tumor  cells  by  using  microsatellite 
instability  assays  to  compare  DNA  isolated  from  formalin-fixed  paraffin-embedded  tumor  samples 
with  DNA  isolated  from  the  patient's  peripheral  blood  white  cells.  (4)  Determine  p53  expression 
using  standardized  immunohistochemical  techniques.  p53  mutation  analysis  will  incorporate 
microdissection-based  topographic  genotyping  and  direct  sequence  analysis.  (5)  Determine  MIB-1 
indices  in  tumor  samples  using  standardized  immunohistochemical  techniques. 

Technical  Approach:  Temozolomide  will  be  given  concurrently  with  radiation  therapy  to  newly 
diagnosed  children  with  High  Grade  Glioma  (HGG)  or  Diffuse  Intrinsic  Pontine  Gliomas  (DIPG) 
on  a  42-day  schedule.  Four  weeks  following  the  completion  of  radiation  therapy  the  patient  will 
receive  temozolomide  daily  for  5  days  beginning  a  new  cycle  every  28  days  for  a  total  of  10  cycles. 
COG  anticipates  about  50  patients  between  the  ages  of  3  and  22  years  of  age  will  be  participating 
in  this  study;  enrollment  at  MAMC  is  estimated  to  be  1  to  2  patients  per  year. 

Progress:  This  protocol  closed  to  enrollment  in  July  2006.  One  MAMC  subject  enrolled  but  died  of 
disease  progression. 


318 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206034  Status:  Ongoing 

Title:  COG  ACNS0423:  A  Phase  II  Study  of  Concurrent  Radiation  and  Temozolomide  Followed 

by  Temozolomide  and  Lomustine  (CCNU)  in  the  Treatment  of  Children  with  High  Grade  Glioma 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  LTC  John  B.  Halligan,  MC;  MAJ 

Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/21/2005  -  Mar  2006  COG/POG  via  The  Geneva  Foundation  11/30/2006 

Study  Objective:  (1)  To  determine  whether  temozolomide  given  during  radiation  therapy 
followed  by  the  combination  of  Temozolomide  and  CCNU  as  adjuvant  therapy  results  in  an 
improvement  in  event-free  survival  compared  to  historical  control  cohorts.  Target  tumors  are:  o 
Anaplastic  Astrocytoma;  Glioblastoma  Multiforme;  Gliosarcoma.  (2)  To  further  assess  the  toxicity 
of  adjuvant  treatment  with  CCNU  and  temozolomide  following  XRT  and  concurrent  temozolomide 
in  a  larger  group  of  patients. 

Laboratory  Correlates:  (1)  Investigate  MGMT  expression  in  formalin-fixed,  paraffin-embedded 
biopsy  specimens  of  brain  tumors  using  immunohistochemical  methods.  (2)  Identify  those  tumors 
in  which  MGMT  expression  is  silenced  by  determining  promoter  CpG  methylation  in  DNA  isolated 
from  formalin-fixed,  paraffin-embedded  tumor  samples.  (3)  Investigate  whether  a  functional  MMR 
system  is  present  in  tumor  cells  by  using  micro  satellite  instability  assays  to  compare  DNA  isolated 
from  formalin-fixed  paraffin-embedded  tumor  samples  with  DNA  isolated  from  the  patient's 
peripheral  blood  white  cells.  (4)  Determine  p53  expression  using  standardized 
immunohistochemical  techniques.  p53  mutation  analysis  will  incorporate  microdissection-based 
topographic  genotyping  and  direct  sequence  analysis.  (5)  Determine  MIB-1  indices  in  tumor 
samples  using  standardized  immunohistochemical  techniques.  (6)  Determine  the  frequencies  of 
GSTM1,  GSTT1,  and  GSTP1  allelic  variants  in  patients  with  high  grade  glioma.  (7)  Determine  the 
level  of  protein  expression  of  GSTP1  in  tumor  specimens.  (8)  Determine  whether  polymorphisms  in 
GSTP1,  GSTM1  and  GSTT1  genes  and  tumor  GSTP1  protein  expression  are  associated  with 
survival,  hypothesizing  that  patients  with  inherent  low  activity  GST  genotypes  and  low  GSTP1 
protein  expression  will  have  increased  survival  time.  (9)  Assess  whether  germline  polymorphisms 
of  the  GST  genes  are  correlated  with  severity  of  chemotherapy  toxicity,  hypothesizing  that 
patients  with  low  activity  GST  genotypes  will  have  decreased  clearance  of  the  metabolites  of 
chemotherapy  agents,  and  thus  will  have  higher  degree  of  toxicity.  (10)  Characterize  allelic 
imbalance  and  copy  number  changes  associated  with  high-grade  gliomas  by  Affymetrix  SNP 
arrays.  (11)  Characterize  gene  expression  changes  associated  with  high-grade  gliomas  by 
Affymetrix  U133plus2  arrays.  (12)  To  correlate  any  identified  chromosomal  abnormalities  and 
differentially  expressed  genes  with  clinical  parameters  such  as  age,  tumor  location,  degree  of 
resection,  histological  grade,  p53  expression,  progression  free  survival,  overall  survival,  treatment 
responses  to  determine  their  prognostic  significance.  (13)  Identify  oncogenes  and  tumor  suppressor 
genes  involved  in  the  pathogenesis  and  malignant  phenotype  of  pediatric  high  grade  gliomas. 

Technical  Approach:  Patients  will  be  given  radiation  therapy  (RT)  to  the  brain  5  days  a  week  for 
6  weeks.  Within  the  first  week  of  starting  RT  the  patient  will  begin  taking  Temozolomide  orally 
(90  mg/m2/day)  and  continue  taking  the  drug  for  42  days  (6  weeks).  After  completion  of  RT  and  the 
6-week  treatment  with  Temozolomide,  patients  will  be  given  no  treatment  for  a  4-week  rest  period. 
During  Maintenance,  patients  will  take  oral  Temozolomide  again,  but  this  time  at  a  higher  dose 
(160  mg/m2/day)  for  five  days  in  a  row  followed  by  a  37  day  break.  In  addition,  patients  will  take 
another  chemotherapy  drug  known  as  Lomustine  (CCNU)  orally  with  the  temozolomide  on  day  1. 


319 


Patients  will  be  treated  on  this  study  for  about  11-12  months.  Expected  enrollment  for  MAMC  is  1- 
2  patients  per  year. 

Progress:  This  protocol  remains  open  to  patient  entry,  no  patients  have  enrolled. 


320 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205084 

Status:  Ongoing 

Title:  COG  AGCT0132,  A  Phase  III  Study  of  Reduced  Therapy  in  the  Treatment  of  Children 
with  Low  and  Intermediate  Risk  Extracranial  Germ  Cell  Tumors 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

11/25/2005  -  Nov  2009  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

5/22/2006 

Study  Objective:  Low  Risk  (LR)  (1)  To  assess  whether  the  proposed  therapeutic  plan  can 
maintain  a  3-year  survival  of  at  least  95%  for  patients  newly  diagnosed  with  Stage  I  gonadal 
malignant  germ  cell  tumors.  (2)  To  determine  the  cytogenetic  and  molecular  genetic  features 
which  correlate  with  clinical  differences  in  behavior.  These  tissues  will  be  banked  for  future 
analyses  of  the  biologic  characteristics  of  malignant  germ  cell  tumors. 

Intermediate  Risk  (IR)  (1)  To  assess  whether  three  cycles  of  3-day  compressed  PEB  chemotherapy 
can  maintain  a  3-year  event-free  survival  of  at  least  92%  for  patients  with  newly  diagnosed  Stage 
II-IV  malignant  testicular  and  Stage  II-III  ovarian  germ  cell  tumors,  newly  diagnosed  Stage  I-II 
non-gonadal  extracranial  malignant  germ  cell  tumors,  or  relapsed/progressed  immature 
teratomas.  (2)  To  determine  the  cytogenetic  and  molecular  genetic  features  which  correlate  with 
clinical  differences  in  behavior.  These  tissues  will  be  banked  for  future  analyses  of  the  biologic 
characteristics  of  malignant  germ  cell  tumors.  (3)  To  assess  whether  three  cycles  of  3-day 
compressed  PEB  chemotherapy  can  maintain  a  3-year  survival  of  at  least  95%  for  patients  with 
newly  diagnosed  Stage  II-IV  malignant  testicular  and  Stage  II-III  ovarian  germ  cell  tumors,  newly 
diagnosed  Stage  I-II  non-gonadal  extracranial  malignant  germ  cell  tumors,  or  relapsed/progressed 
immature  teratomas  with  malignant  components. 

Cancer  Control  Objectives  (1)  To  estimate  the  percentage  of  patients  with  Stage  I  ovarian  and 
Stage  I  testicular  GCTs  for  whom  chemotherapy  can  be  eliminated  in  the  first  three  years 
following  diagnosis.  (2)  To  estimate  the  percentage  of  intermediate  risk  patients  requiring  only 
three  cycles  of  therapy.  (3)  To  delineate  the  acute  toxicities  and  long  term  sequelae  associated  with 
therapy  compression.  These  will  be  compared  with  historical  data  available  from  CCG-8882/POG- 
9049.  (4)  To  determine  the  number  of  hospital  days  and  total  drug  dosages  required  for  the 
compressed  therapy.  These  will  be  compared  with  historical  data  available  from  CCG-8882/POG- 
9049.  (5)  To  compare  the  number  of  protocol  directed  treatment  days  of  CCG-8882  with  the 
number  of  treatment  days  used  in  AGCT0132. 

Tumor  Biology  Objectives  (1)  To  collect  samples  and  facilitate  studies  of  germ  cell  tumor 
cytogenetics  and  molecular  genetics  including  deletion,  mutation  and  imprinting  on  chromosomes 
1  and  6,  and  amplification  of  c-myc.  (2)  To  derive  tumor  cell  lines  and  xenografts  of  germ  cell 
tumors  for  use  in  studies  of  biologic  agents  and 

differentiation  agents.  (3)  To  establish  a  biologic  samples  bank  for  germ  cell  tumors  to  include 
frozen  tumor  and  frozen  normal  tissue  that  may  be  used  in  future  studies. 

Technical  Approach:  AGCT0132  is  a  Phase  III  Study  of  Reduced  Therapy  in  the  Treatment  of 
Children  with  Low  and  Intermediate  Risk  Extracranial  Germ  Cell  Tumors.  This  study  would  avoid 
chemotherapy  in  low  risk  testicular/ovarian  germ  cell  tumors  by  using  surgery  and  observation.  If 
during  observation  the  tumor  markers  do  not  return  to  normal  or  become  abnormal,  the  patient 
will  be  treated  with  chemotherapy  in  3  cycles  over  a  period  of  9  weeks.  Each  treatment  will  involve 
3  anti-cancer  drugs:  cisplatin,  etoposide,  and  bleomycin.  In  patients  with  intermediate  risk  the 


321 


standard  therapy  would  be  surgery  plus  chemotherapy.  The  purpose  of  this  study  would  be  to 
decrease  the  total  amount  of  chemotherapy  given  from  4  cycles  to  3.  The  number  of  days 
chemotherapy  would  be  given  would  also  decrease  from  5  to  3  days  in  each  treatment  cycle. 

Progress:  This  protocol  remains  open  to  enrollment,  with  no  patients  enrolled. 


322 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203024  Status:  Ongoing 

Title:  COG  AHOD0031,  A  Phase  III  Group-wide  Study  of  Dose-intensive  Response-based 
Chemotherapy  and  Radiation  Therapy  for  Children  and  Adolescents  with  Newly  Diagnosed 
Intermediate  Risk  Hodgkin  Disease 


Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 


Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion: 

1/13/2003  -  Mar  2008 

Funding:  Periodic  Review: 

COG/POG  via  The  Geneva  Foundation  12/12/2006 

Study  Objective:  (1)  To  compare  response-based  therapy  to  standard  therapy  for  intermediate 
risk  Hodgkin  disease.  (2)  To  determine  whether  involved  field  radiation  therapy  (IFRT)  can  be 
eliminated  based  upon  early  and  complete  response  to  multiagent  chemotherapy.  (3)  To  determine 
whether  the  addition  of  an  additional  two  cycles  of  chemotherapy  (DECA)  can  improve  outcome  in 
those  with  a  slow  early  response  to  standard  chemotherapy.  (4)  To  prospectively  collect 
information  on  the  individual  prognostic  significance  of  the  following  presenting  factors: 
erythrocyte  sedimentation  rate,  circulating  levels  of  IL-100,  each  of  the  "B"  symptoms  -  fever, 
night  sweats,  weight  loss,  nodal  aggregate  >  6cm,  large  mediastinal  mass>  1/3  thoracic  diameter 
and  number  of  involved  nodal  sites,  histology,  albumin,  blood  counts,  sex  and  age.  (5)  To  study  the 
reliability  and  utility  of  [18F]  -  Fluorodeoxyglucose  (FDG)  Imaging  (PET  scans)  as  an  imaging 
modality  in  Hodgkin  disease.  (6)  To  determine  the  frequency  and  severity  of  late  effects  of  therapy 
including  thyroid  dysfunction,  infertility,  cardiotoxicity,  pulmonary  toxicity  and  second  malignant 
neoplasms.  (7)  To  serve  as  the  therapeutic  companion  to  biology  and  late  effects  studies  in 
Hodgkin  disease  and  correlate  those  results  with  response  to  therapy,  event  free- survival  and 
overall  survival. 

Technical  Approach:  All  patients  will  receive  3  cycles  of  ABVE-PC  three  weeks  apart  followed 
by  a  re-evaluation  of  disease.  Those  with  a  rapid  early  response  will  receive  an  additional  1  cycle  of 
ABVE-PC  three  weeks  later  followed  by  another  re-evaluation  of  disease.  Rapid  early  responders, 
who  have  sustained  a  complete  response  following  a  total  of  4  cycles  of  ABVE-PC  chemotherapy, 
will  be  randomized  to  omit  (reduced  therapy  arm)  or  receive  consolidative  low  dose  involved  field 
radiation  therapy  (IFRT)  (standard  therapy  arm).  Those  with  less  than  a  complete  response  will 
receive  IFRT.  Patients  with  a  slow  early  response  to  3  cycles  of  ABVE-PC  will  be  randomized  to 
receive  1  additional  cycle  of  ABVE-PC  (standard  therapy  arm)  alone  versus  1  additional  cycle  of 
ABVE-PC  preceded  by  2  cycles  of  DECA  (augmented  therapy  arm)  .  All  patients  who  are  slow 
early  responders  will  receive  consolidative  low  dose  IFRT.  Patients  with  less  than  a  complete 
response  after  consolidative  radiation  therapy  or  those  with  progressive  disease  at  any  time  will  be 
treated  at  the  discretion  of  the  treating  physician  after  consultation  with  the  study  chair. 

Progress:  This  protocol  remains  open  to  patient  entry  with  two  patients  enrolled,  none  during 
FY06.  One  patient  had  recurrent  disease  and  enrolled  in  another  COG  protocol.  The  other  patient 
continued  to  be  followed  at  MAMC. 


323 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205047 

Status:  Completed 

Title:  COG  AHOD00P1,  A  Pilot  Study  of  Re-Induction  Chemotherapy  with  Ifosfamide,  and 
Vinorelbine  (IV)  in  Children  with  Refractory/Relapsed  Hodgkin  Disease 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

5/31/2005  -  Jan  2006  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

1/24/2006 

Study  Objective:  (1)  To  determine  the  response  rate  of  the  re-induction  regimen 
ifosfamide/vinorelbine  (IV)  with  filgrastim  overall  and  within  the  cohorts  of  minimally  pre¬ 
treated/low  risk  and  heavily  pre-treated/high  risk  patients  with  relapsed/refractory  Hodgkin 
disease.  (2)  To  evaluate  ifosfamide/vinorelbine  (IV)  with  filgrastim  as  a  re-induction  regimen  in 
minimally  pretreated/low  risk  pediatric  patients  with  relapsed/refractory  Hodgkin  disease. 
Specifically,  to  determine:  (a)  the  cardiac,  hepatic,  renal,  and  hematologic  toxicity,  and  toxic  death 
rate  and  (b)  the  proportion  of  patients  able  to  mobilize  sufficient  hematopoietic  stem  cells  (CD34+) 
after  2  cycles  of  IV.  To  collect  data  regarding  tumor  biologic  characteristics  in  patients  with 
relapsed/refractory  Hodgkin  disease  (a)  To  determine  the  incidence  of  hyper  mutability  in  Hodgkin 
patients  by  longitudinal  genotoxic  bio-monitoring  and  (b)  To  determine  the  prognostic  significance 
of  biologic  markers  including  serum  IL-10  receptor,  serum  IL-2  receptor,  p53,  and  mdm-2. 

Technical  Approach:  This  is  a  phase  II  pilot  study  of  re-induction  chemotherapy  with  Ifosfamide 
and  Vinorelbine  (IV)  in  children  with  refractory/relapsed  Hodgkin  disease.  Subjects  will  have  two 
cycles  of  chemotherapy,  Ifosfamide  and  Vinorelbine,  at  least  21  days  apart.  Filgrastim  will  be 
given  on  day  6  of  each  cycle,  or  anytime  tests  show  the  white  blood  cell  count  is  too  low,  to  help 
white-blood  cells  grow.  Subjects  will  be  evaluated  at  the  end  of  cycle  2.  Subject's  whose  disease 
worsens  will  be  taken  off  study  therapy.  Subject's  whose  disease  remains  the  same  will  have  a 
stem  cell  collection  and  then  be  taken  off  study  therapy.  Subject's  whose  disease  responds  to 
treatment  will  have  a  stem  cell  collection  at  the  end  of  cycle  two.  Stem  cell  transplantation  will  not 
be  performed  at  MAMC;  subjects  will  be  referred  to  a  COG  approved  bone  marrow  transplant 
center. 

Progress:  COG  closed  enrollment  in  March  2006,  with  no  subjects  enrolled  at  MAMC. 


324 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  205014 

Status:  Ongoing 

Title:  COG  AHOD0321,  A  Phase  II  Study  of  Weekly  Gemcitabine  and  Vinorelbine  in  Children 
with  Recurrent  or  Refractory  Hodgkin  Disease 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding: 

12/6/2004  -  Dec  2005  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

10/24/2006 

Study  Objective:  To  determine  the  response  rate  after  weekly  administration  of  the  combination 
of  gemcitabine  and  vinorelbine  to  patients  with  recurrent  or  refractory  Hodgkin  Disease.  To 
document  the  toxicity  of  weekly  administration  of  gemcitabine  and  vinorelbine  in  patients  with 
recurrent  or  refractory  Hodgkin  Disease. 

Technical  Approach:  This  is  a  Phase  II  study  of  weekly  Gemcitabine  and  Vinorelbine  In  children 
with  recurrent  or  refractory  Hodgkin  Disease.  This  study  will  evaluate  the  use  of  a  new  re¬ 
induction  chemotherapy  regimen  consisting  of  the  anti-cancer  drugs  combination  of  gemcitabine 
and  vinorelbine  in  patients  who  have  previously  been  treated  for  Hodgkin  Disease.  Patients  will 
receive  at  least  two  cycles  (21  days  each)  of  weekly  GEM/VINO  therapy.  The  goal  is  to  determine  if 
the  combination  of  these  is  active  against  recurrent  Hodgkin  Disease  and  to  find  out  what  effects 
this  drug  combination  will  have.  Patients  with  any  response  after  the  first  two  cycles  may  elect  to 
proceed  directly  to  stem  cell  transplantation.  Those  with  stable  disease  after  the  first  two  cycles, 
will  receive  a  minimum  of  two  more  cycles  of  GEM/VINO.  At  the  end  of  the  fourth  cycle,  patients 
without  progressive  disease  can  remain  on  study  and  continue  to  receive  GEM/VINO  or  go  off 
study  for  alternative  therapy.  About  26  patients  between  the  ages  of  0  to  <30  years  of  age  will  be 
participating  in  this  study. 

Progress:  This  protocol  remains  open  to  enrollment  with  one  patient  enrolled  who  is  off  study 
treatment  but  continued  to  be  followed  at  MAMC  after  having  gone  through  bone  marrow 
transplant. 


325 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201108  Status:  Ongoing 

Title:  COG  ANBL00B1,  Neuroblastoma  Biology  Studies 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

6/26/2001  -  May  2007  COG/POG  via  The  Geneva  Foundation  5/23/2006 

Study  Objective:  (1)  To  prospectively  analyze  the  factors  that  are  currently  used  for  risk-group 
assignment  (DNA  content  by  flow  cytometry,  MYCN  copy  number  by  FISH,  and  tumor  histology 
using  the  International  Neuroblastoma  Pathologic  Classification  System)  in  neuroblastoma 
tumors  at  the  time  of  diagnosis,  (2)  to  maintain  a  reference  bank  containing  clinically  and 
genetically  characterized  frozen  tumor  tissue,  tumor  DNA  and  RNA,  tumor  touch  preparations, 
histology  slides  and  blocks,  cell  lines,  and  paired  normal  DNA  obtained  at  the  time  of  diagnosis  (all 
patients),  at  the  time  of  second-look  surgery  (high-risk  patients),  and  relapse  (all  patients)  for 
future  research  studies,  (3)  to  prospectively  analyze  the  prevalence  of  lp,  llq,  14q  LOH  and  gain 
of  17q;  the  expression  of  nerve  growth  factor  (NGF)  and  its  high  affinity  (Trk-A)  and  low  affinity 
(p75  NTR)  receptors;  and  telomerase  activity  in  diagnostic  neuroblastoma  tumors,  and  to 
determine  the  independent  clinical  significance  of  these  biologic  factors  compared  to  MYCN 
amplification,  INSS  stage,  age,  and  histologic  variables  in  predicting  either  response  to  treatment 
or  outcome,  (4)  to  build  a  database  of  the  known  biologic  prognostic  factors  for  patients  on 
therapeutic  studies,  (5)  to  serve  as  a  Registry  for  neuroblastoma  patients  whose  tumors 
demonstrate  clinical  and  genetic  features  defined  as  "Low  Risk"  for  treatment  failure  in  the 
absence  of  adjuvant  therapy,  and  (6)  A  secondary  objective  of  this  study  is  to  prospectively  analyze 
the  role  of  ferritin,  LDH,  and  Imaging-defined  risk  factors  identified  at  the  time  of  diagnosis  in 
risk  assessment. 

Technical  Approach:  Clinical  and  biological  factors  have  been  shown  to  have  prognostic  value  in 
neuroblastoma.  Current  therapeutic  studies  for  neuroblastoma  patients  are  tailored  according  to 
patient  risk.  In  the  Children's  Oncology  Group  (COG),  risk-group  assignment  is  currently  based  on 
INSS  stage,  age,  MYCN  copy  number,  tumor  cell  ploidy,  and  Shimada  tumor  histopathology. 
However,  additional  factors  have  also  been  shown  to  have  prognostic  value  including  the  level  of 
Trk-A  expression,  multi-drug  resistance  associated  protein  (MRP)  expression,  telomerase  activity, 
CD44  expression,  and  genetic  abnormalities  including  LOH  of  lp,  llq,  14q  and  gain  of  17q.  We 
hypothesize  that  analyzing  additional  genetic  and  biologic  factors  will  result  in  a  further 
refinement  of  the  current  COG  risk-group  schema,  and  will,  thereby,  impact  future  risk-based 
approaches  to  therapy.  We  further  hypothesize  that  maintaining  tumor  and  nucleic  acid  banks 
with  well  characterized  samples  will  provide  invaluable  biologic  resources  for  future  research 
studies  that  will  lead  to  a  further  understanding  of  neuroblastoma  biology  and  the  development  of 
new,  effective  therapy  for  high-risk  patients. 

Progress:  This  study  remains  open  to  patient  entry,  with  three  patients  enrolled  at  MAMC,  two 
during  FY06.  One  patient  was  transferred  to  Seattle  Children's  Hospital  in  July  2006.  Data  on  the 
two  remaining  patients  continued  to  be  submitted  to  COG. 


326 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205069  Status:  Completed 

Title:  COG  ANHL0121,  A  Phase  II  Study  of  Rituximab  (IND#7028)  and  Ifosfamide,  Carboplatin 
and  Etoposide  (ICE)  Chemotherapy  in  Children  with  Recurrent/Refractory  B-cell  (CD20+)  Non- 
Hodgkin  Lymphoma  and  B-cell  Acute  Lymphoblastic  Leukemia 


Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 


Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion: 

7/6/2005  -  Nov  2007 

Funding: 

COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

4/20/2006 

Study  Objective:  Primary  Aims:  (1)  To  determine  the  response  and  relapse-free  survival  rates  to 
chemotherapy  with  ifosfamide,  Carboplatin,  and  etoposide  plus  rituximab  for  patients  with 
recurrent/refractory  CD  20+  NHL  and  B-cell  ALL.  (2)  To  evaluate  the  toxicity  profile  of  this 
therapy  regimen.  Specifically,  the  frequency  of  therapy  delays  between  courses  due  to  prolonged 
Grade  4  hematologic  toxicity  will  be  monitored.  Secondary  Aims:  (1)  To  determine  whether 
ifosfamide,  Carboplatin,  and  etoposide  in  combination  with  rituximab  and  G-CSF  will  result  in 
mobilization  of  greater  than  2  x  106/kg  peripheral  blood  stem  cells  (CD34+  cells,  PBSC)  in  at  least 
80%  of  patients  for  whom  peripheral  stem  cell  collection  is  performed.  (2)  To  evaluate  the  time 
course  of  engraftment  for  patients  who  undergo  peripheral  stem  cell  transplantation  following 
collection  of  stem  cells  using  this  mobilization  regimen.  (3)  To  collect  tumor  specimens  to  permit  an 
evaluation  of  gene  expression  profiles  in  patients  with  recurrent/refractory  CD20+  NHL  and  B-cell 
ALL.  (4)  To  collect  tumor  and  other  specimens  to  permit  the  identification  of  patient- specific 
markers  for  use  in  evaluation  of  presence  and  significance  of  minimal  residual  disease. 

Technical  Approach:  This  study  will  address  adding  an  investigational  drug,  Rituximab,  to 
standard  chemotherapy  called  ICE  (ifosfamide,  Carboplatin,  and  etoposide)  in  an  attempt  to 
improve  the  outcome  of  patients  who  have  not  responded  well  to  standard  treatment  alone. 
Patients  will  be  on  this  study  for  up  to  three  months,  depending  on  how  the  disease  is  responding 
to  treatment.  Patients  who  have  disease  which  gets  worse  after  one  course  of  chemotherapy  will 
not  continue  on  the  study  drugs.  Patients  who  have  disease  that  stays  the  same  or  responds  at  all 
to  treatment  will  receive  a  second  course  of  therapy.  There  will  be  a  third  course  of  therapy  for 
patients  who  show  a  continued  response.  Some  patients  may  have  peripheral  blood  stem  cells 
collected  during  therapy  which  would  be  stored  and  used  later  in  case  patients  need  more 
treatment. 

Progress:  This  protocol  closed  to  accrual  on  23  Oct  2006,  with  no  MAMC  subjects  enrolled. 


327 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  200049  Status:  Ongoing 

Title:  COG  D9902,  A  COG  Soft  Tissue  Sarcoma  Diagnosis,  Biology  and  Banking  Protocol 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

2/22/2000  -  Feb  2010  COG/POG  via  The  Geneva  Foundation  1/19/2006 

Study  Objective:  (1)  To  facilitate  the  collection  of  human  tissue  and  other  biologic  specimens 
(blood,  bone  marrow)  from  Intergroup  Rhabdomyosarcoma  Study  Group  (IRSG)  investigators,  (2) 
To  provide  a  repository  for  long-term  storage  of  tissue  and  other  biologic  specimens  (blood,  bone 
marrow)  collected  by  IRSG  investigators  (referred  to  as  the  Bank),  and  (3)  To  make  available, 
through  the  IRSG/Cooperative  Human  Tissue  Network,  these  materials  for  approved  projects  by 
laboratory-based  investigators. 

Technical  Approach:  At  the  time  of  initial  diagnosis  of  rhabdomyosarcoma  or  undifferentiated 
sarcoma  (or  at  re-excision  of  the  primary  tumor,  if  it  occurs  prior  to  the  start  of  chemotherapy), 
surgical  tissue,  bone  marrow  and  blood  that  are  no  longer  needed  for  diagnosis  will  be  prepared 
and  shipped  to  the  Pediatric  Cooperative  Human  Tissue  Network  (CHTN)  for  Banking  and 
Distribution. 

Progress:  This  protocol  is  open  to  patient  entry  with  two  patients  enrolled  at  MAMC,  none  during 
FY06.  Both  patients  have  moved  out  of  the  MAMC  area.  Follow  up  data  is  not  required  under  this 
tissue  banking  protocol. 


328 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  98090  Status:  Ongoing 

Title:  COG  P9442:  National  Wilms  Tumor  Late  Effects  Study 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/17/1998  -  Indef  COG/POG  via  The  Geneva  Foundation  6/20/2006 

Study  Objective:  To  determine  (1)  the  frequency  of  Wilms  tumor  and  other  cancers  in  family 
members  of  Wilms  tumor  patients  in  order  to  estimate  the  recurrence  risk  in  siblings  and 
offspring;  test  the  plausibility  of  specific  genetic  modes  of  inheritance  in  homogeneous  subgroups; 
and  identify  familial  cancer  syndromes  (if  any)  that  may  involve  Wilms  tumor,  (2)  To  determine 
fertility  rates  of  Wilms  tumor  patients  and  rates  of  perinatal  mortality,  low  birth-weight  and 
adverse  pregnancy  outcomes  in  relation  to  the  type  and  amount  of  cancer  treatment  received  in 
childhood,  (3)  To  estimate  the  rates  of  selected  congenital  defects  and  of  specified  single  gene 
disorders  (sentinel  phenotypes)  in  the  offspring  of  Wilms  tumor  patients,  (4)  to  estimate  the  rates 
of  second  malignancy  neoplasms  in  relation  to  the  dosage  of  radiation  therapy  and  the  use  of 
specific  chemotherapeutic  agents  (Actinomycin  D,  doxorubicin,  Cytoxan  and  etoposide)  received  in 
childhood,  (5)  to  compare  the  incidence  rate  of  congestive  heart  failure  among  Wilms  tumor 
survivors  in  relation  to  the  dose  of  radiation  therapy  received  to  abdomen  and/or  lungs  and  to  the 
use  of  specific  chemotherapeutic  agents. 

Technical  Approach:  The  large  number  of  Wilms  tumor  survivors  ascertained  by  the  NWTS 
during  its  first  twenty  years  of  operation  constitutes  an  ideal  cohort  for  the  study  of  familial  risk 
and  late  effects  of  treatment.  Four  protocol  studies  have  been  conducted;  treatment  protocols  and 
results  for  the  first  three  studies  have  been  published.  A  large  fraction  of  the  total  national  U.S. 
incidence  of  Wilms  tumor  has  been  registered  on  these  studies,  probably  as  much  as  70%  of  an 
estimated  450-500  cases  occurring  nationally  since  1980.  Over  2,500  children  who  were  followed  on 
NWTS  treatment  protocols  have  now  survived  5  or  more  years  since  their  original  diagnosis.  Many 
of  those  treated  more  than  a  decade  ago  have  reached  sexual  maturity,  so  that  their  reproductive 
history  and  the  status  of  their  offspring  may  be  evaluated  by  entry  into  this  study. 

Progress:  This  protocol  remains  open  to  enrollment  with  no  subjects  enrolled  to  date  at  MAMC. 


329 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  201054  Status:  Completed 

Title:  COG  P9934:  Systemic  Chemotherapy,  Second  Look  Surgery  and  Conformal  Radiation 

Therapy  Limited  to  the  Posterior  Fossa  and  Primary  Site  for  Children  >  8  Months  and  <  3  Years 

with  Non-metastatic  Medulloblastoma  -  A  Children's  Oncology  Group  Phase  III  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  COL  John  D.  Werschkul,  MC;  COL 

Marc  G.  Cote,  MC;  LTC  William  B.  Reece,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

1/23/2001  -  Jan  2006  COG/POG  via  The  Geneva  Foundation  1/4/2006 

Study  Objective:  (1)  To  determine  if  the  proposed  treatment  for  children  >  8.0  months  and  <  3 
years  of  age  at  registration  with  non-metastatic  (M0)  medulloblastoma  is  more  effective  than  the 
combined  treatments  given  to  children  of  the  same  age  and  extent  of  disease  on  POG  9233,  as 
measured  by  event-free  survival  (EFS)  rates,  (2)  to  assess  the  feasibility  and  safety  of  the  planned 
use  of  second  look  surgery  and  focal  conformal  radiation  therapy  following  chemotherapy,  (3)  to 
determine  the  acute  and  chronic  toxicities  associated  with  the  above  treatment  regimens,  (4)  to 
describe  the  neuropsychological  and  neuroendocrine  effects  of  this  systemic  chemotherapy, 
surgery,  and  local,  conformal  radiation,  (5)  to  determine  the  feasibility  and  validity  of  a  centralized 
telephone  interview  based  data  collection  method  for  neuropsychological  evaluations,  and  (6)  to 
determine  the  incidence  of  atypical  teratoid/rhabdoid  tumor  (AT/RT)  in  children  enrolled  on  this 
study. 

Technical  Approach:  In  this  study  for  young  children  with  relatively  low  risk  medulloblastoma, 
we  will  test  a  new  therapeutic  approach  which  begins  with  maximal  safe  tumor  resection  and  a  16- 
week,  4-drug  induction  chemotherapy  regimen  of  cyclophosphamide,  vincristine,  cisplatin,  and  oral 
etoposide.  In  comparison  to  the  chemotherapy  regimens  of  studies  8633  and  9233,  cisplatin  is 
introduced  earlier,  and  given  concurrently  with  the  other  agents.  As  well,  etoposide  is  given  in  an 
oral  form.  Based  upon  the  compelling  data  that  outcome  is  clearly  linked  to  a  complete  surgical 
resection  the  proposed  therapy  includes  a  'second  look'  surgery  following  induction  chemotherapy 
in  an  attempt  to  resect  residual  disease  in  those  patients  who  have  failed  to  achieve  a  complete 
response  to  chemotherapy.  To  improve  local  control  rates  this  clinical  trial  will  test  the  use  of 
conformal  radiation  therapy  and  will  determine  if  these  techniques  can  reduce  radiation-related 
side  effects.  Following  recovery  from  the  initial  phase  of  treatment,  patients  will  receive  a 
maintenance  phase  of  chemotherapy,  using  cyclophosphamide,  vincristine,  and  the  prolonged 
administration  of  oral  etoposide,  to  complete  one  year  of  therapy. 

Progress:  This  protocol  closed  enrollment  in  June  2006,  with  no  subjects  enrolled  at  MAMC. 


330 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  205105  Status:  Ongoing 

Title:  COG-LTF,  A  Groupwide  Process  for  Collecting  Long  Term  Follow  Up  Data 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC;  MAJ  Melissa  A.  Forouhar,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

7/12/2005  -  indef  COG/POG  via  The  Geneva  Foundation  6/20/2006 

Study  Objective:  The  specific  objective  is  to  establish  a  single  mechanism  for  regular  annual 
local  Institutional  Review  Board  (IRB)  approval  for  COG  member  institutions  by  aggregating 
protocols  for  which  only  follow-up  data  collection  is  needed. 

Technical  Approach:  This  document  is  designed  to  facilitate  follow-up  data  collection  for 
Children's  Oncology  Group  (COG)  studies  that  are  closed  to  accrual  and  for  which  all  patients  in 
an  institution  have  completed  therapy.  This  includes  studies  that  originated  in  the  Children's 
Cancer  Group  (CCG),  the  Pediatric  Oncology  Group  (POG),  the  Intergroup  Rhabdomyosarcoma 
Study  Group  (IRSG),  and  the  National  Wilms  Tumor  Study  Group  (NWTSG)  as  well  as  new  COG 
studies. 

Progress:  This  protocol  remains  ongoing  with  31  patients  now  being  followed  under  this  long¬ 
term  administrative  protocol.  No  patients  were  entered  during.  Twenty  nine  continued  to  be 
followed;  two  are  not  lost  to  follow  up. 


331 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  94092  Status:  Ongoing 

Title:  POG  9351/CCG  7921:  Trial  of  Doxorubicin,  Cisplatin,  and  Methotrexate  With  and  Without 
Ifosfamide,  With  and  Without  Muramyl  Tripeptide  Phosphatidyl  Ethanolamine  (MTP-PE)  for 
Treatment  of  Osteogenic  Sarcoma 


Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 


Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion: 

4/21/1995  -  Indef 

Funding: 

COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

3/21/2006 

Study  Objective:  (1)  To  improve  the  survival  of  patients  with  osteogenic  sarcoma,  (2)  To  compare 
the  results  of  a  prospective,  randomized  trial  of  two  chemotherapeutic  regimens  in  the  treatment 
of  osteogenic  sarcoma,  (3)  To  compare  the  results  of  a  combined  chemotherapeutic  regimen  (high- 
dost  methotrexate,  cisplatin,  and  doxorubicin)  given  pre-operatively  and  post-operatively  to  a 
similar  regimen  using  the  same  drugs  and  adding  ifosfamide,  (4)  To  test  whether  the  early 
introduction  of  ifosfamide  results  in  a  higher  rate  of  good  histologic  response  at  the  time  of 
definitive  surgery,  (5)  To  determine  whether  histologic  response  assessed  after  longer  pre¬ 
operative  chemotherapy  with  more  drugs  predicts  disease-free  survival  with  the  same  power  as 
observed  in  CCG-782  which  used  a  shorter  period  of  pre-operative  chemotherapy  and  fewer  drugs, 
(6)  To  determine  whether  liposomal  muramyl  tripeptide-phosphatidyl  ethanolamine  (MTP-PE, 

CGP  19835a),  a  stimulator  of  macrophage  function,  can  improve  disease-free  survival  for  patients 
with  osteogenic  sarcoma,  (7)  To  determine  whether  multiple  drug  resistance  gene-encoded  P- 
glycoprotein  expression  is  useful  for  determine  prognosis  or  assigning  therapy. 

Technical  Approach:  This  study  is  a  phase  III,  prospective,  randomized  trial  of  two 
chemotherapy  regimens  for  the  treatment  of  newly  diagnosed,  previously  untreated  osteogenic 
sarcoma.  One  regimen  calls  for  the  administration  of  high-dose  methotrexate,  doxorubicin,  and 
cisplatin.  The  other  regimen  calls  for  the  administration  of  these  agents  plus  ifosfamide. 
Chemotherapy  is  administered  for  10  weeks  prior  to  surgical  resection  of  the  primary  tumor  and 
any  metastatic  disease  (CCG  patients).  Patients  also  are  randomly  assigned  either  to  receive 
muramyl  tripeptide  (MTP-PE)  with  maintenance  chemotherapy  or  to  receive  maintenance 
chemotherapy  alone. 

Progress:  This  protocol  closed  to  patient  entry  November  1997,  with  two  patients  enrolled.  One 
patient  chose  to  discontinue  treatment  and  the  other  patient  completed  study  therapy.  Long-term 
follow-up  data  continues  to  be  submitted  annually  to  COG  on  both  patients. 

A  final  report  on  this  protocol  was  submitted  by  the  study  chair,  Paul  Meyers,  M.D.,  26  October 
2004.  Summary  of  recommendations  and  future  plans:  Regimen  A,  which  calls  for  cisplatin, 
doxorubicin,  and  high  dose  methotrexate,  achieved  EFS  at  least  as  good  as  regimen  B,  which  calls 
for  the  same  three  agents  with  the  addition  of  ifosfamide.  Regimen  A  had  less  toxicity  than 
regimen  B.  Until  an  appropriate  prospective  randomized  trial  is  available,  regimen  A  should  be 
considered  standard  therapy  for  osteosarcoma.  The  interaction  between  MTP  and  ifosfamide  needs 
further  study.  In  vitro  analysis  of  the  interaction  should  be  encouraged  and  clinical  trials 
considered  of  the  combination  in  patients  at  the  time  of  recurrence. 


332 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  95058  Status:  Completed 

Title:  POG  9400:  ALinC  16  Classification  (C)  Protocol 
Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding:  Periodic  Review: 

12/16/1994  -  Indef  COG/POG  via  The  Geneva  Foundation  11/15/2005 

Study  Objective:  (1)  To  continue  to  characterize  the  biologic  findings  of  the  acute  lymphoblastic 
and  undifferentiated  leukemias  (immunologic  markers,  ploidy  (DNA  index),  karyotyping, 
morphology)  and  their  relationship,  as  prognostic  factors  for  attaining  and  maintaining  remission, 
(2)  To  apply  to  therapy  selection,  the  determination  that  ploidy  and  certain  structural 
chromosomal  abnormalities  predict  poor  prognosis,  (3)  To  evaluate  the  usefulness  of  PCR 
technique  in  detecting  minimal  residual  disease  in  patients  with  disease  demonstrating  t  (  9;  2  2  ) 
or  t  (  1;  19  )  chromosomal  abnormalities,  (optional),  (4)  To  apply  to  therapy  selection  molecular 
testing  for  llq23  translocation  in  infants  <  12  months  of  age  with  acute  lymphocytic  leukemia,  (5) 
To  determine  the  roll  of  p53  and  pl6  tumor  suppressor  genes  in  T-ALL.  (optional),  (6)  Individual 
patient  outcome  will  be  compared  with  the  leukemia  cell  proliferation  response  to  ask  if 
proliferation  in  response  to  a  myeloid  growth  factor  is  associated  with  an  increased  risk  of 
developing  AML.  (optional),  (7)  To  determine  risk  group  assessment  using  Fluorescent  In-Situ 
Hybridization  (FISH)  screening  for  Trisomies  4  and  10  in  Non-T,  Non  B  ALL,  and  (8)  To  determine 
if  drug  sensitivity  profiles  of  blast  cells  for  three  commonly  used  chemotherapeutic  agents  - 
Adriamycin,  Methotrexate,  and  Cytarabine  correlate  with  a)  initial  response  b)  subsequent 
development  of  relapse. 

Technical  Approach:  A  bone  marrow  aspirate  (a  needle  stick  in  hip  bone  to  draw  marrow  into 
syringe)  will  be  done  to  prove  or  disprove  diagnosis  of  leukemia.  If  leukemia  is  present,  it  is 
important  to  identity  the  exact  type  and  subtype  of  leukemia,  in  order  to  plan  treatment.  This 
typing  requires  that  several  laboratory  tests  be  run  on  the  leukemia  cells  in  the  bone  marrow.  As 
we  perform  the  bone  marrow  aspiration  we  will  be  removing  enough  bone  marrow  (about  2-1/2 
teaspoons)  to  run  the  laboratory  tests.  We  may  also  need  to  draw  some  blood  (about  2-1/2 
teaspoons)  from  a  vein  to  send  for  studies.  Some  of  these  tests  will  be  done  here  and  some  will  be 
sent  to  reference  laboratories  in  other  Pediatric  Oncology  Group  institutions  for  different  kinds  of 
special  tests  to  identify  the  characteristics  of  the  leukemia  cells. 

Progress:  This  protocol  closed  to  patient  entry  in  November  1999,  with  nine  patients  enrolled. 

One  patient  has  been  reported  lost  to  follow  up,  one  patient  transferred  to  another  COG 
institution,  one  patient  relapsed,  and  six  patients  continue  to  be  followed.  COG  reported  the 
protocol  completed  31  March  2000,  with  a  final  accrual  of  4211  (842  per  year).  Hard  copy  of  the 
final  report  has  been  placed  in  the  protocol  file. 


333 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  96097 

Status:  Ongoing 

Title:  POG  9440:  National  Wilms  Tumor  Study  -  5:  Therapeutic  Trial  and  Biology  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

4/19/1996  -  Indef  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

3/21/2006 

Study  Objective:  (1)  To  increase  the  survival  rate  of  children  with  favorable  histology  Wilms 
tumor  and  other  renal  tumors  of  childhood,  (2)  to  determine  if  loss  of  heterozygosity  for 
chromosome  16q  markers  in  tumor  tissue  is  associated  with  a  poorer  prognosis  for  children  with 
favorable  histology  Wilms  tumor,  (3)  to  determine  if  loss  of  heterozygosity  for  chromosome  lp 
markers  in  tumor  tissue  is  associated  with  a  poorer  prognosis  for  children  with  favorable  histology 
Wilms  tumor,  (4)  to  determine  if  increased  DNA  content  in  tumor  cells  is  associated  with  a  poorer 
prognosis,  (5)  to  decrease  the  acute  and  long  term  morbidity  of  treatment  of  children  with  Wilms 
tumor,  (6)  to  improve  the  survival  of  patients  with  unfavorable  histology  tumors  including  Wilms 
tumor  with  diffuse  anaplasia  and  clear  cell  sarcoma  of  the  kidney  by  using  a  new  treatment 
regimen  that  includes  etoposide  and  cyclophosphamide,  (7)  to  improve  survival  of  patients  with 
malignant  rhabdoid  tumor  of  the  kidney,  (8)  to  study  biology  and  pathology  of  patients  who 
present  with  bilateral  Wilms  tumor,  (9)  to  conduct  hypothesis-driven  trials  led  by  diagnostic 
radiologists  in  order  to  develop  guidelines,  and  (10)  to  establish  a  biological  samples  bank 
containing  touch  preparations,  paraffin  blocks,  frozen  tumor,  normal  kidney  tissue,  and  serum  and 
urine. 

Technical  Approach:  This  proposed  therapeutic  trial  involves  a  number  of  experimental 
regimens  that  are  designed  either  to  reduce  treatment  for  the  subgroup  of  patients  with  the  most 
favorable  prognosis,  or  to  intensify  treatment  for  several  subgroups  with  the  least  favorable 
prognosis.  Patients  will  be  stratified  into  the  appropriate  treatment  regimens  by  age,  size  of  tumor 
at  diagnosis  and  staging  of  the  tumor  (Stages  1-V)  with  favorable/unfavorable  histology,  including 
rhabdoid,  clear  cell  sarcomas  and  Wilms  tumor  with  diffuse  or  focal  anaplasia.  Treatment  will 
include  nephrectomy  or  surgical  debulking  of  tumor,  radiation  therapy  to  abdomen  and/or  lungs, 
and  appropriate  chemotherapy  regimens. 

Progress:  This  protocol  closed  to  patient  entry  in  June  2002,  with  two  patients  enrolled  who 
continued  to  be  followed  at  MAMC  during  FY06. 


334 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  200018 

Status:  Completed 

Title:  POG  P9761:  Phase  II  Trial  of  Irinotecan  in  Children  with  Refractory  Solid  Tumors:  A 

COG  Study 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

11/19/1999  -  Nov  2004  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

10/14/2005 

Study  Objective:  (1)  To  determine  the  efficacy  of  Irinotecan  in  the  treatment  of  children  with 
refractory  neuroblastoma,  sarcomas  of  soft  tissue  or  bone,  other  solid  tumors,  or  brain  tumors,  (2) 
to  further  evaluate  the  toxicity  of  Irinotecan  when  given  daily  for  5  days,  repeated  every  21  days, 
and  (3)  to  further  evaluate  the  pharmacokinetics/pharmacodynamics  of  Irinotecan  and  its 
metabolites  SN-38,  SN  38G,  and  APC,  using  a  limited  sampling  strategy. 

Technical  Approach:  Irinotecan  appears  to  be  one  of  the  most  active  topoisomerase  I  inhibitors 
that  is  clinically  available  and  therefore  deserves  further  evaluation  in  children  with  recurrent 
CNS  or  solid  tumors.  Although  the  optimal  schedule  for  Irinotecan  is  not  yet  known,  antitumor 
activity  has  been  observed  on  all  schedules  of  administration.  Pharmacokinetic  studies,  an  integral 
component  of  this  trial  will  be  done  to  determine  if  there  are  correlates  with  PK  parameters  and 
toxicity  or  response. 

Progress:  This  protocol  reached  its  accrual  goals  and  was  reported  completed  in  November  2005. 
One  patient  had  been  enrolled  at  MAMC  during  FY00,  but  died  due  to  progressive  disease. 


335 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  200048 

Status:  Ongoing 

Title:  POG  P9851:  Osteosarcoma  Biology  Protocol,  Companion  to  Group-Wide  Therapeutic 

Studies 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

2/22/2000  -  Feb  2010  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

1/18/2006 

Study  Objective:  (1)  To  increase  our  understanding  of  the  basic  biology  of  these  tumors,  with  a 
distinct  possibility  that  new  therapeutic  targets  may  be  uncovered.  Examples  of  this  type  are 
ErbB-2  and  methotrexate  resistance  factors,  (2)  To  develop  a  set  of  biologic  prognostic  indicators 
which  can  be  measured  at  diagnosis  and  which  will  be  predictive  of  response  and  outcome  in 
osteosarcoma.  These  could  then  be  used  in  subsequent  treatment  programs  to  determine  therapy, 
avoiding  excessive  toxicity  to  good  risk  patients  and  reserving  alternative,  more  intensive  therapy 
for  those  at  standard  risk.  Examples  include  loss  of  heterozygosity  at  Rb  and  MDR,  (3)  To 
determine  the  feasibility  of  various  assays  and  to  develop  a  reliable  mechanism  of  distributing 
osteosarcoma  samples  to  various  intergroup  investigators,  with  centralized  reporting  of  laboratory 
results  and  adequate  quality  control. 

Technical  Approach:  At  the  time  of  biopsy  or  surgery  (definitive  or  recurrence),  tumor  tissue 
that  is  not  needed  for  diagnosis  will  be  processed  and  forwarded  to  the  Cooperative  Human  Tissue 
Network  (CHTN)  for  distribution.  Specimens  will  include:  tumor  tissue  (Formalin-fixed  or 
formalin-fixed  paraffin  embedded  block  or  30  unstained  slides;  blood  samples  (heparinized  (10  ml), 
serum  (14  ml)).  Assays  being  performed:  MDR  Immunohistochemistry  (University  of  Rochester); 
MDR  Functional  Assays/MRP  (Memorial  Sloan-Kettering);  Methotrexate  Transport  &  Metab 
(Memorial  Sloan-Kettering) ;Topoisomerase  II  (Yale  University);  Bcl-2/Bax  (Yale  University); 
Rb/p53  (Fels  Institute);  ErbB-2  (Memorial  Sloan-Kettering);  MDM2  (Memorial  Sloan-Kettering); 
pl6/p21  (Hospital  for  Sick  Children);  LOH  at  3q,18q  (Fels  Institute);  sis,gli,fos  (Yale  University); 
SV40  (University  of  Colorado);  myc,RAS  (Memorial  Sloan-Kettering);  metalloproteinase  (Yale 
University);  c-met/HGF  (Yale  University);  IGF-I/IGF-IR  (University  of  Maryland);  Telomerase  (St. 
Jude  Children's);  Ploidy  (Dana  Farber). 

Progress:  In  July  2006,  COG  reported  that  this  companion  protocol  would  be  phased  out  and 
expected  to  close  accrual  within  six  months  after  the  new  protocol  is  up  and  running.  One  patient 
was  enrolled  at  MAMC  and  continues  to  be  followed,  pending  close-out  of  this  protocol  by  COG. 


336 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  203105 

Status:  Completed 

Title:  POG  P9962  A  Phase  II  Study  of  Intrathecal  Topotecan  in  Patients  with  Refractory 
Meningeal  Malignancies 

Principal  Investigator:  MAJ  Kenneth  H.  Lieuw,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  COL  Kelly  J.  Faucette,  MC 

Start  -  Completion:  Funding: 

11/17/2003  -  Aug  2008  COG/POG  via  The  Geneva  Foundation 

Periodic  Review: 

7/27/2005 

Study  Objective:  (1)  To  determine  the  therapeutic  activity  (response  rate  and  time  to  CNS 
progression  of  intrathecal  Topotecan  in  patients  with  recurrent  or  refractory  neoplastic  meningitis. 
(2)  To  further  assess  the  safety/toxicity  of  intrathecal  Topotecan  in  the  treatment  of  patients  with 
neoplastic  meningitis.  (3)  To  evaluate  the  concentration  of  matrix  metalloproteinases  (MMPs)  in 
the  CSF  of  patients  with  recurrent  or  refractory  neoplastic  meningitis. 

Technical  Approach:  A  Phase  II  study  for  children  and  adolescents,  1-21  years  of  age  with 
neoplastic  meningitis  using  Topotecan  administered  directly  into  the  cerebrospinal  fluid  to 
stabilize  or  shrink  the  cancer  and  give  relief  of  cancer  symptoms. 

Progress:  COG  permanently  closed  this  protocol  7  April  2006,  due  to  low  accrual.  No  patients 
enrolled  at  MAMC. 


337 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206045  Status:  Completed 

Title:  The  Pontine  Valentine  Leucocidin  Virulence  Factor  in  Staph  Aureus  Disease:  A 
Retrospective  Study  Analyzing  CA-MRSA  Incidence  and  Clinical  Severity 

Principal  Investigator:  CPT  Ashley  M.  Maranich,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  Mary  P.  Fairchok,  MC;  MAJ  Steven  D.  Mahlen,  MS 

Start  -  Completion:  Funding:  Periodic  Review: 

1/19/2006  -  Jun  2006  DCI  N/A 

Study  Objective:  Primary  objectives  are  to  determine  the  proportion  of  Panton-Valentin 
leukocidin  (PVL)  positive  strains  of  Staphylococcus  aureus  isolated  in  the  MAMC  Clinical 
Microbiology  Lab  and  to  determine  if  PVL  positivity  is  correlated  with  CA-MRSA  strains. 
Secondary  objectives  are  to  compare  the  clinical  course  of  infections  with  PVL  positive  strains  and 
PVL  negative  strains  through  chart  review. 

Technical  Approach:  538  clinical  isolates  of  S.  aureus  have  been  tested  by  the  MAMC  clinical 
microbiology  lab  for  PVL  toxin  positivity  by  real-time  PCR.  This  study  proposes  to  access  these 
results  and  exclude  duplicate  isolates  from  the  same  infection  as  well  as  isolates  that  were 
obtained  for  surveillance  purposes  only,  then  determine  the  proportion  of  isolates  that  were  PVL 
positive  and  separately  analyze  the  proportion  that  were  PVL  positive  for  CA-MRSA  versus 
nosocomial  MRSA  and  MSSA  strains.  Antibiotic  susceptibility  (to  include  D-test  status  for 
erythromycin  inducible  clindamycin  resistance)  will  be  accessed  to  categorize  the  strains  as  MSSA, 
nosocomial  MRSA  and  CA-MRSA. 

Outpatient  and  inpatient  charts  will  be  assessed  from  patients  corresponding  to  the  S.  aureus 
isolates  and  reviewed  for  the  following  clinical  parameters:  severity  of  infection,  type  of  infection, 
need  for  hospitalization,  antibiotic  regimen  prescribed,  route  of  antibiotic  administration  (IV  vs. 

PO  vs.  both),  necessity  for  incision  and  drainage,  number  of  clinic  and/or  ED  visits  related  to 
infection,  recurrence  of  disease,  prescription  of  eradication  regimen. 

Progress:  This  protocol  was  reported  completed  in  June  2006.  Results:  Complete  data  was 
available  for  331  of  407  samples  (82%).  MRSA  was  more  likely  to  be  PVL+  than  MSSA  (166/201; 
81%  versus  31/130;  24%),  p=.001.  Disease  characteristics  associated  with  all  PVL-  strains  were  the 
same  as  the  MRSA  PVL+  subset,  with  the  exception  that  there  was  no  increased  need  for  I&D  in 
the  MRSA  PVL+  versus  PVL-  strains.  Although  PVL+  strains  were  less  likely  to  require 
hospitalization,  they  were  associated  with  more  outpatient  visits  than  PVL-  strains  (3.56  versus 
2.55,  p<.02). 

Conclusion:  PVL  is  more  likely  to  be  associated  with  methicillin-resistance  and  community- 
acquired  SA  infections.  However,  the  study  found  that  PVL+  strains  were  less  likely  to  cause 
invasive  disease  needing  IV  antibiotics  or  hospitalization.  Controlling  for  MRSA+,  PVL+  strains 
were  also  no  more  likely  to  require  I&D  than  PVL-  strains.  However,  PVL  does  seem  to  cause  a 
higher  healthcare  burden  with  more  recurrence  and  an  increased  number  of  outpatient  visits. 


338 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  204040  Status:  Ongoing 

Title:  National  Cystic  Fibrosis  Foundation  Patient  Data  Registry 
Principal  Investigator:  COL  (Ret)  Donald  R.  Moffitt,  MD 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  Dana  A.  Winter,  C.R.T. 

Start  -  Completion:  Funding:  Periodic  Review: 

2/6/2004  -  Indef  DCI  1/13/2006 

Study  Objective:  (1)  Monitoring  epidemiologic  trends  in  the  population  for  CF  patients  in  the  US 
through  data  collection  and  entry  into  the  NCF  Foundation  Patient  Registry.  (2)  Assist  in 
development  of  therapeutic  advances  responsible  for  the  improved  survival  of  cystic  fibrosis 
patients. 

Technical  Approach:  The  CF  Patient  Data  Registry  will  include  patients  with  cystic  fibrosis  who 
are  cared  for  at  CF  Care  Centers  throughout  the  U.S.  Locally,  this  project  will  include  patients 
from  the  CF  Care  Center  at  Madigan  Army  Medical  Center,  which  currently  cares  for  27  CF 
patients.  When  a  patient  and/or  parent  gives  written  consent  to  be  included  in  the  registry, 
updates  of  the  patient's  medical  information  will  be  sent  to  the  CF  National  Patient  Registry.  The 
information  that  is  sent  to  the  National  Patient  Registry  includes  patient  name,  date  of  birth, 
social  security  number,  and  zip  code  of  residence.  Personal  identifiers  allow  the  CF  National 
Patient  Registry  to  track  information  for  patients  who  receive  care  at  more  than  one  CF  center  or 
who  move  between  CF  centers.  Patients  have  the  choice  of  participating  in  the  registry  without 
sending  the  patient's  social  security  number  to  the  CF  National  Patient  Registry.  Other 
information  that  is  sent  to  the  CF  National  Patient  Registry  includes  the  following:  specifics  of 
diagnosis  (e.g.,  diagnosis  date,  sweat  test  results,  genotype);  clinical  status  (e.g.,  presence  of 
complications,  transplant  status);  test  results  (e.g.,  pulmonary  function  tests,  microbiology 
cultures);  nutritional  status  (e.g.,  height,  weight,  nutritional  supplements,  pancreatic  enzyme  use); 
treatment  information  (e.g.,  hospitalizations,  home  therapies,  use  of  new  therapies  );  participation 
in  clinical  trials;  and  demographic  data  (e.g.,  educational  status,  marital  status,  employment 
status,  and  insurance  coverage). 

Progress:  This  database  protocol  remains  open  to  enrollment,  with  18  patients  enrolled  MAMC, 
none  during  FY06.  Patient  data  continues  to  be  collected  and  submitted  to  the  Cystic  Fibrosis 
Foundation  on  MAMC  patients  enrolled. 


339 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  204028 

Status:  Ongoing 

Title:  Pediatric  Intubation  Training  Utilizing  the  Ferret  (mustela  putorius  furo)  Model 

Principal  Investigator:  LTC  Robert  A.  Puntel,  MC 

Department:  Pediatrics 

Facility:  MAMC 

Associate  Investigator(s):  MAJ  Catherine  Kimball-Eayrs,  MC 

Start  -  Completion:  Funding: 

12/17/2003  -  Dec  2006  DCI 

Periodic  Review: 

11/8/2006 

Study  Objective:  This  is  a  training  protocol  using  a  ferret  model  to  teach  physicians  and  other 
health  care  professions  how  to  endotracheally  intubate  (i.e.  place  a  plastic  tube  in  the  windpipe) 
neonates  and  infants.  The  training  is  part  of  a  two-day  course  in  pediatric  life-saving  techniques; 
the  class  is  called  Pediatric  Advanced  Life  Support  (PALS)  and  is  developed  by  the  American 
Heart  Association.  PALS  is  offered  through  the  Department  of  Emergency  Medicine  two  to  four 
times  a  year. 

Technical  Approach:  Students  will  complete  classroom  instruction  in  principles  and  techniques 
of  pediatric  life  support.  The  students  will  then  practice  techniques,  include  endotracheal 
intubation,  on  mannequins.  Following  this  practice,  students  will  intubate  an  anesthetized  ferret, 
which  more  closely  simulates  the  respiratory  anatomy  and  reflexes  of  a  human  child  than  does  a 
mannequin.  Up  to  six  ferrets  will  be  used  for  each  training  session  and  each  ferret  will  serve  to 
train  four  physicians  or  other  health  care  providers.  The  ferrets  will  be  fully  anesthetized  and  will 
experience  no  pain  during  the  procedure;  they  will  be  closely  monitored  and  observed  by  a  member 
of  the  veterinary  staff.  During  the  procedure,  each  of  the  course  participants  will  learn  to  place  a 
small  plastic  tube  through  the  mouth  and  into  the  trachea  (windpipe)  of  an  anesthetized  ferret 
with  the  assistance  of  a  small,  lighted  metal  blade  called  a  laryngoscope.  The  investigators,  other 
course  instructors,  and  veterinary  staff  will  directly  supervise  the  procedure.  If  any  ferret  is 
traumatized  or  shows  signs  of  problems  with  the  anesthetic  drugs,  the  procedure  will  be  stopped 
on  that  animal.  No  animal  will  undergo  more  than  seven  intubation  attempts.  After  the  training 
session  is  complete,  the  animals  will  be  allowed  to  wake  up  from  anesthesia  and  will  be  returned 
to  their  usual  housing  at  the  MAMC  Animal  Facility.  In  the  first  days  following  the  procedure,  the 
ferrets  may  experience  a  mild  sore  throat,  and  they  will  be  offered  moist  food  as  needed.  Ferrets 
will  be  housed  and  maintained  according  to  standard  animal  husbandry  protocols. 

Progress:  Four  PALS  courses  were  held  in  FY  2006  with  88  medical  personnel  successfully 
trained  using  many  simulators  and  10  ferrets  for  tracheal  intubation  training.  With  the  new 
SimBaby  model,  ferret  use  is  less  than  in  previous  years.  Expect  to  eventually  phase  out  use  of 
live  animals  due  to  the  quality  of  simulation  trainers  becoming  available.  Four  labs  are  planned 
for  FY  2007. 


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Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  203046  Status:  Ongoing 

Title:  Telemedicine  Based  Ultrasound  for  Detecting  Neonatal  Heart  Disease  in  Babies  at 

Remote  Military  or  Native  American  Health  Care  Facilities 

Principal  Investigator:  LTC  Robert  A.  Puntel,  MC 

Department:  Pediatrics  Facility:  MAMC 

Associate  Investigator(s):  COL  James  B.  Kinney,  MC;  COL  David  T.  Estroff,  MC;  David  J. 

Sahn,  MD;  COL  (Ret)  Edward  R.  Carter,  MD;  Mark  D.  Reller,  MD 

Start  -  Completion:  Funding:  Periodic  Review: 

7/22/2003  -  Dec  2006  DCI  via  Grant  1/24/2006 

Study  Objective:  This  impact  and  outcomes  research  proposal  will  specifically  test  the  hypothesis 
that  a  method  for  reliable  and  rapid  assessment  of  newborn  infants  at  risk  for  heart  disease  can  be 
developed  for  telediagnosis  using  a  small  hand-held  ultrasound  system  with  an  appropriate  high 
frequency  transducer.  The  unique  setting  will  be  that  the  healthcare  professional  performing  the 
examination  may  not  be  a  cardiologist  or  a  fully  trained  echocardiographer,  but  the  examination 
will  be  monitored,  supervised  and  guided  using  telemedicine  links  which  will  also  allow  control  of 
the  scanning  system  settings  by  the  remote  supervisor  who  is  an  expert  Pediatric 
Cardiologist/echocardiographer. 

\The  program  will  assess  diagnostic  accuracy  as  the  primary  outcome  variable  and  time  to 
diagnosis,  incidence  of  unnecessary  transport  and  length  of  stay  during  initial  hospitalization 
including  transfer  when  it  occurs,  as  secondary  medical  outcomes.  Diagnosis  will  be  established  by 
testing  at  a  referral  center  or  examination  and  ultrasound  performed  by  the  expert  consultant  on  a 
follow-up  visit  occurring  at  the  referral  site.  In  addition  to  any  diagnostic  findings  of  significance 
which  are  missed,  we  will  survey  and  document  adverse  events  in  the  patient's  subsequent  course, 
both  medical  and  social  (e.g:  parent/baby  separation,  parental  anxiety).  Each  infant  will  be 
followed  for  3  months  from  the  time  of  the  initial  diagnosis  encounter  and  will  be  compared  to 
historical  controls.  Finally,  our  study  will  also  include  a  financial  outcomes/cost  analysis. 

Technical  Approach:  This  is  a  prospective,  non-randomized,  case-control  study  with 
measurements  obtained  at  baseline  (entry  into  the  study)  and  three  months  later.  Source  data  will 
consist  of  ultrasound  images  of  the  heart  transmitted  electronically  from  a  remote  site  to  a  medical 
center  where  they  will  be  read  and  interpreted.  Non-transmitted  U/S  images  and  data  abstracted 
from  the  infant's  medical  record  will  be  recorded.  Data  will  be  obtained  at  baseline  and  three 
months  following  baseline. 

Recruitment  and  training  of  health  care  professionals:  two  individuals  -  a  pediatrician,  family 
practitioner  or  obstetrical  nurse  from  each  designated  participating  center  will  be  identified. 

Initial  training  in  the  use  of  handheld  ultrasound  systems  will  occur  at  MAMC  by  Drs.  Kinney  and 
Puntel  and  will  consist  of  2  days  of  classroom  and  individual  hands-on  instruction.  A  primer  on 
ultrasound  instrumentation  and  methods  for  performance  of  cardiac  ultrasound  will  be  prepared 
by  Drs.  Sahn,  Kinney  and  Puntel.  Infants  whose  families  consent  will  be  examined  by  the 
attending  pediatric  cardiologist  and  have  hands-on  scanning  performed  by  the  trainees  under  his 
supervision  as  the  infant's  condition  allows. 

When  the  portable  scanner  becomes  available  for  each  center  and  the  Telemedicine  link  is 
installed  and  activated,  one  of  the  four  pediatric  cardiologists  staffing  this  program  will  visit  with 
the  trainees  at  each  institution  to  bring  the  scanner  and  operate  the  telemedicine  link,  see 
patients  and  observe  the  trainees  performing  ultrasound  examinations,  especially  in  newborns. 
They  will  certify  on  that  examination  and/or  by  follow-up  observation  of  Telemedicine  observed 


341 


studies  by  those  healthcare  provider-trainees  when  they  are  qualified  to  activate  their  site  and 
enroll  patients. 

Enrollment  of  patients  will  begin  when  all  training  has  been  completed  and  each  center  has 
completed  its  own  IRB  process.  Other  care  of  and  testing  of  the  infant  will  be  performed  as 
necessary  by  the  hospital  staff  and  results  will  be  extracted  from  the  patient's  medical  record. 
Physical  examination,  EKG,  and/or  X-ray  will  be  used,  as  routinely  in  a  neonatal  setting,  for 
identification  of  potential  signs,  symptoms,  physical  examination  findings,  EKG  or  radiologic 
findings  of  congenital  heart  disease.  Cyanosis  will  be  detected  by  saturation  meter  and/or  blood 
gases  as  necessary.  These  are  part  of  routine  Level  II  nursery  care  for  newborn  infants  and  will 
not  be  altered  by  the  study.  These  protocols  and  methods  may  be  specific  to  the  site  and 
documented  in  the  approval  of  these  sites  as  level  2  or  level  3  nurseries. 

Progress:  This  protocol  remains  ongoing  and  open  to  enrollment,  with  44  subjects  enrolled  at 
MAMC  for  training  purposes;  19  in  FY06.  An  additional  ten  subjects  enrolled  at  Bassett  in  FY06, 
all  subjects  received  a  TeleECHO  diagnosis  confirmed  100%  with  follow-up  conventional 
echocardiography.  One  patient  was  diagnosed  with  Tetralogy  of  Fallot;  underwent  heart  surgery 
and  is  doing  well.  Twelve  TeleECHO  training  sessions  have  been  completed  and  17  doctors 
trained;  three  sessions  and  seven  doctors  in  FY06.  Doctors  Kinney,  Puntel,  and  Sahn  are  now 
privileged  to  practice  telemedicine  at  all  sites  except  Yukon.  All  sites,  except  Yukon,  have  received 
the  necessary  medical  equipment  for  the  study  and  arrangement  are  beginning  to  swap  out 
equipment  per  CRAD A/SOW.  At  this  time  Bassett,  Weed,  American  Native,  Elmendorf,  and 
Bayne-Jones  have  received  IRB  approval.  Blanchfield  will  resubmit  to  the  IRB  once  a  new  PI 
completes  all  requirements.  Oak  Harbor  and  Bremerton's  protocol  is  scheduled  for  another  review 
December  13,  2006  at  Naval  Medical  Center  San  Diego.  Yukon  is  still  on  hold  due  to  staff 
constraints.  HSRRB  is  currently  reviewing  all  IRB  approved  protocols.  Madigan,  Bassett,  Weed, 
American  Native,  and  Bremerton  have  received  approvals  to  connect  to  local  area  networks. 


342 


Detail  Summary  Sheets 

Department  of  Pharmacy 


343 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206092  Status:  Completed 

Title:  Assessment  of  LDL-Cholesterol  Goal  Attainment  Among  Patients  at  a  Very  High  Risk  For 
Secondary  Cardiovascular  Events  in  a  Pharmacist-Managed  Lipid  Clinic 

Principal  Investigator:  Helen  S.  Booth,  PharmD 

Department:  Pharmacy  Facility:  MAMC 

Associate  Investigator(s):  Emily  V.  Leaf,  PharmD;  Terri  G  Foster,  MA,  R.Ph 

Start  -  Completion:  Funding:  Periodic  Review: 

5/22/2006  -  May  2006  DCI  N/A 

Study  Objective:  To  identify  patients  at  very  high  risk  for  secondary  cardiovascular  events  who 
are  unable  to  attain  the  newly  recommended  LDL-cholesterol  goal,  and  to  determine  the  reasons 
for  them  not  being  able  to  attain  their  goal. 

Technical  Approach:  All  patients  treated  by  Madigan  Army  Medical  Center  Internal  Medicine 
Lipid  Clinic  during  the  study  period  will  be  considered  for  analysis.  Internal  Medicine  Lipid 
Clinic's  Access™  database  and  the  health  system's  electronic  medical  record  system  (AHLTA, 
ICDB,  CHCS)  will  be  used  for  data  collection  (patient  age,  gender,  cardiovascular  risk  factors, 
LDL-cholesterol  level,  anti-lipid  medication  therapy,  and  reported  adverse  medication  events). 
Excel™  database  will  be  used  to  maintain  collected  data.  Patients  meeting  the  inclusion  criteria 
will  be  identified  from  the  data  collection  and  chart  reviews  conducted  on  patients  meeting  the 
inclusion  criteria.  The  number  of  patients  identified  to  be  at  very  high  risk  for  secondary 
cardiovascular  events,  the  percentage  of  patients  attaining  their  new  LDL-cholesterol  goal, 
medications  utilized  to  attain  the  goal,  and  the  documented  reasons  for  patients  not  being  able  to 
attain  the  goal  will  be  reported. 

Progress:  A  total  of  145  patients  were  identified  to  have  LDL-C  goal  of  <  70.  Seventy-five  patients 
have  reached  their  goal  and  70  patients  have  not  reached  their  goal.  Of  75  patients  who  reached 
their  goal,  41  %  was  on  a  statin  monotherapy,  3%  on  other  monotherapy,  1%  on  no  medications, 
and  the  rest  of  patients  were  on  a  combination  therapy.  Of  70  patients  who  did  not  reach  their 
goal,  63%  were  in  titration  phase,  26%  had  no  further  treatment  options,  10%  were  lost  to  follow¬ 
up,  and  1%  was  non-compliant.  This  data  was  presented  at  American  Society  of  Health- Systems 
Pharmacists  Summer  Meeting  2006. 


344 


Detail  Summary  Sheets 

Department  of  Preventive  Medicine 


345 


Detail  Summary  Sheet 

Date:  30  Sep  06  Number:  206056 

Status:  Completed 

Title:  Will  Power:  Is  Personal  Motivation  Associated  with  Retention 

in  the  Army? 

Principal  Investigator:  CPT  Hieu  V.  Hoang,  MC 

Department:  Preventive  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  ETC  Andrew  R.  Wiesen,  MC 

Start  -  Completion:  Funding: 

1/31/2006  -  Jun  2006  DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  determine  the  association  between  personal  motivation  and  retention  in  the 
Army  among  Soldiers  processed  through  the  Physical  Disability  Evaluation  System. 


Technical  Approach:  Cases  will  be  randomly  selected  from  Fort  Lewis'  electronic  archive 
database  for  years  2001-2005  and  self-identifiers  used  to  match  subjects  with  their  paper  records. 
Once  the  study  is  completed,  self-identifier  information  will  be  omitted  from  the  database.  A 
limited  database  will  be  constructed  for  this  study  to  include  subjects'  sex,  age,  marital  status, 
rank,  MOS,  LOS,  AD  or  reserve  status,  medical  diagnosis,  and  motivation. 

Progress:  This  protocol  was  reported  completed  in  June  2006.  The  Medical  Board  is  an 
administrative  process  whereby  Soldiers  with  a  medical  disability  are  evaluated  to  determine 
fitness  for  duty.  This  cohort  study  attempted  to  better  understand  the  role  of  personal  motivation 
and  its  associate  with  retention  in  the  Army.  We  postulated  that  personal  motivation  is  positively 
correlated  with  retention.  Logistic  regression  was  used  to  evaluate  predictors  of  retention  in 
Soldiers  with  a  disability  undergoing  the  medical  board  process.  Self-expressed  motivation  as 
measured  by  a  single  question  was  the  strongest  predictor  of  fitness  determination.  Motivation 
was  highly  influential  in  6  cases  where  the  PEB  had  recommended  separation,  however  all  6  cases 
indicated  a  desire  to  remain  on  active  duty  and  were  found  fit  at  the  end.  In  addition,  older  age, 
active  duty  status,  MOS  of  combat  support  service,  and  medical  diagnosis  were  found  to  be 
statistically  significant  predictors  of  retention.  It  is  difficult  to  say  if  the  studied  question  truly 
captures  one's  motivation,  and  research  is  warranted  to  better  assess  motivation  more  accurately. 


346 


Detail  Summary  Sheet 


Date:  30  Sep  06 

Number:  206066 

Status:  Completed 

Title:  Self  Identification  as  a  Predictor  of  Subsequent  Mental  Health  Diagnosis 

Principal  Investigator:  LTC  Victoria  R.  Hughes,  MC 

Department:  Preventive  Medicine 

Facility:  MAMC 

Associate  Investigator(s):  None. 

Start  -  Completion: 

3/22/2006  -  May  2006 

Funding: 

DCI 

Periodic  Review: 

N/A 

Study  Objective:  To  determine  if  an  association  exists  between  self-identification  of  a  mental 
health  concern  and  the  diagnosis  of  a  psychiatric  disorder  by  a  psychiatrist  or  psychologist  among 
Soldiers  returning  from  Operation  Iraqi  Freedom  (OIF). 


Technical  Approach:  All  Soldiers  with  1-25  Stryker  Brigade  returning  from  OIF,  will  be  followed 
to  see  if  at  any  time  during  the  5  month  (October  2005  to  March  30,  2006)  post-deployment 
timeframe  they  were  diagnosed  with  any  of  the  following  specific  psychiatric  diagnosis 
[International  Classification  for  Diseases-9th  edition]  (ICD-9)  code(s):  adjustment  disorder  (309, 
309.0  -.9),  PTSD  (309.81),  depression  (296.2,  296.3  300.4,  311),  acute  stress  disorder  (308,  308.0  to 
.3),  anxiety/panic  attacks  (300.00,  300.01,  300.02,  330.21)  and  suicidal  ideation  (300.9)  by  a 
provider  specifically  trained  in  the  area  of  behavioral/mental  health  i.e.  psychologist  or 
psychiatrist.  MAMC  Health  Outcomes  Management  Division  will  provide  the  dates  for  the 
following:  completion  of  post-deployment  health  assessment  (DD  2796),  SWAPP  and  the 
psychiatric  diagnosis. 

Progress:  Results:  Of  the  original  3,151  in  the  Brigade  that  returned  from  Operation  Iraqi 
Freedom  (OIF),  250  (8%)  were  eliminated  because  they  had  been  previously  diagnosed  with  a 
mental  health  illness.  This  left  2,901  to  be  in  the  study  group  to  take  the  initial  post  deployment 
health  risk  assessment  (PDHRA)  upon  return  from  OIF.  Of  these  2,901,  just  over  57%  (1,672) 
remained  on  the  military  installation  for  the  entire  14  month  study  period.  The  median  age  was 
26;  the  most  common  age  was  24,  with  an  age  range  of  19  to  54.  Fifty  percent  were  white,  and 
nearly  37%  were  single.  A  majority  of  the  Soldiers  were  enlisted  (86%),  with  a  high  school 
education  or  less  (57%)  and  only  4%  were  female.  Demographic  information  that  was  not 
completed  by  the  Soldiers  on  the  questionnaires  is  labeled  as  unspecified  in  their  respective 
categories.  After  completion  of  the  Post  Deployment  Health  Risk  Assessment  (PDHRA),  33  (2.0%) 
Soldiers  were  referred  to  see  a  mental  health  provider.  Of  those  referred,  7  (21.2%)  were  diagnosed 
with  a  mental  health  illness  and  26  (78.8%)  were  not  diagnosed  with  a  mental  health  illness.  Of 
the  1,639  (98.0%)  who  had  not  indicated  a  mental  health  concern  and  therefore  had  not  been 
referred  to  see  a  mental  health  provider  108  (6.6%)  were  later  diagnosed  with  a  mental  health 
illness,  and  1,531  (93.4%)  were  not  diagnosed  during  the  14  month  study  period  at  the  military 
installation's  medical  facility.  This  study  looked  at  the  six  most  common  mental  health  diagnoses 
diagnosed  in  those  who  have  had  war/combat-zone  experience,  a  total  of  115  diagnoses  made  from 
October  2004  to  December  2005.  Adjustment  disorder  was  diagnosed  in  47  Soldiers,  depression  in 
26,  anxiety/panic  attacks  in  25,  PTSD  in  10,  and  acute  stress  reaction  in  7.  Of  the  10  Soldiers 
diagnosed  with  PTSD,  none  were  self  identified.  Suicidal  ideation  was  not  self  identified  by  any  of 
the  Soldiers,  nor  was  suicidal  ideation  diagnosed  in  any  of  the  Soldiers. 

Conclusions:  This  study  shows  that  early  self  identification  of  mental  health  concerns  is  not 
predictive  of  a  clinical  diagnosis  from  a  mental  health  provider  at  a  military  clinic  within  14 
months.  There  were  more  mental  health  diagnoses  made  for  those  who  did  not  initially  self 
identify  with  having  a  mental  health  concern  when  taking  the  PDHRA.  This  suggests  the  idea  that 
some  mental  health  symptoms  develop  over  time  after  a  traumatic  experience.  A  second,  later, 


347 


assessment  may  need  to  be  done  to  improve  its  predictive  value.  The  mental  health  diagnoses 
made  were  relatively  rare;  115  (6.9%)  out  of  a  cohort  of  1,672.  These  results  are  low  compared  to 
the  12%  diagnosed  in  Hoge's  study  published  March  2006.  The  number  of  positive  self 
identifications  for  a  mental  health  concern  is  minimal  at  33,  compared  to  the  number  of  non  self 
identifications  of  a  mental  health  concern  at  1,639.  Single  Soldiers  appear  to  be  more  at  risk  of 
being  diagnosed  with  a  mental  health  illness.  Being  married  possibly  helps  a  soldier  in  coping  with 
mental  health  concerns.  Only  5%  of  married  Soldiers  had  a  positive  mental  health  diagnosis, 
compared  to  9%  of  single  Soldiers  and  95%  married  Soldiers  were  not  diagnosed  with  a  mental 
health  illness.  Marriage  most  likely  provides  for  a  good  support  system  that  is  accessible,  while 
those  who  are  not  married  may  have  support  systems  that  are  less  easily  available.  None  of  the 
Soldiers  diagnosed  with  PTSD  were  initially  self  identified  at  the  time  the  PDHRA  was  completed. 
This  is  most  likely  the  case  because  it  may  take  up  to  several  months  after  the  traumatic  event  for 
someone  to  actually  develop  signs  and  symptoms  of  PTSD.  It  is  also  possible  that  mental  health 
providers  do  not  want  to  give  a  soldier  a  mental  health  diagnosis  right  away. 

On  site  mental  health  diagnoses  are  probably  the  tip  of  iceberg  for  post-  combat  mental  health 
illness,  given  how  few  diagnoses  were  made.  Assessments  done  immediately  upon  return  miss 
many  Soldiers.  Signs  and  symptoms  for  post  traumatic  mental  health  illnesses  do  not  manifest 
immediately.  Mobility  of  the  cohort  limited  the  ability  to  have  continuity  of  care.  Many  Soldiers 
were  not  available  to  take  the  second  health  risk  assessment  given  at  3  to  6  months  after  return 
from  OIF.  This  may  have  prevented  some  Soldiers  from  self  identifying  a  mental  concern  and 
possibly  from  even  realizing  that  maybe  they  were  having  symptoms  when  asked  specific  mental 
health  questions.  Of  those  1,672  around  for  the  entire  14  months,  only  799  took  the  Health  Risk 
Assessment  II.  Why  the  compliance  was  so  low  in  taking  the  second  assessment  is  not  completely 
clear.  Several  possible  reasons  are  that  Soldiers  were  out  in  the  field  training,  that  they  were  on 
vacation  or  sick,  or  that  they  just  did  not  want  to  go  to  take  the  assessment.  Once  it  was  noticed 
that  the  numbers  were  low,  those  responsible  for  conducting  the  assessment  decided  to  take  the 
assessment  to  the  Soldiers.  Effective  mental  health  programs  for  military  service  members  are 
essential.  The  military  command  needs  to  be  aware  and  responsive  to  young,  single,  low  ranking 
Soldiers  returning  from  a  war/combat-zone  who  may  experience  more  mental  health  issues  then 
other  Soldiers. 


348 


Detail  Summary  Sheet 


Date:  30  Sep  06  Number:  206074 

Status:  Completed 

Title:  Military  Rank  as  a  Risk  Factor  for  Type  2  Diabetes 

Principal  Investigator:  LTC  Carol  A.  Moores,  MC 

in  Military